Specialist Compliance Full Package Montvale NJ

Essential Job Function:

Responsible for interacting with customers on quality issues. Responsible for the receipt of all Notices of Investigations and logging them into the Investigations spreadsheet.

Responsible for the receipt of independent CAPAs and logging them into the CAPA spreadsheet.

Responsible for reviewing investigation reports for accuracy, compliance and completion.

Responsible for performing internal and external audits and completing the pertinent audit agenda and reports.

General Information: Experience in the pharmaceutical industry.

Bachelor’s Degree in Science field desired.

JOB RESPONSIBILITIES INCLUDE BUT NOT LIMITED TO:

  • Investigate deviations and initiate the appropriate corrective and/or preventive actions to prevent re-occurrence of the incident.
  • Perform root cause analysis.
  • Perform product impact assessment of deviations.
  • Provide QA support during the investigation process.
  • Perform tracking and trending of deviations and CAPAs.
  • Prepare Deviation and CAPA metrics on a monthly basis.
  • Provide support during FDA inspections.
  • Responsible for the receipt all Notices of Investigations and logging them into the Investigations spreadsheet.
  • Responsible for the receipt of independent CAPAs and logging them into the CAPA spreadsheet.
  • Communicate all deviations to the appropriate customer.
  • Receive all customer complaints, log them into the spreadsheet and forward them to the appropriate department for investigation.
  • Identify quality/compliance deficiencies and report them to Compliance Management.
  • Initiate change controls related to CAPAs or process improvements.
  • Perform internal and external audits and complete pertinent agenda and reports.
  • Conduct pre-inspection audits internally to assess areas of regulatory risk in preparation for inspections/audits by regulatory agencies and/or clients.
  • Identify, report and investigate trends associated with deviations.
  • Write trend investigations as required.

Resumes to jobs@jobsbl.com

Regional Sales Manager CA,OR,WA, Hi Great Healthcare Company

 JOB  TITLE:          Regional Sales Manager Pacific

PURPOSE:

 Develop and direct sales and related marketing activities through the respective field sales personnel assigned to the region and/or with designated dealers, group practices, and labs. Develop and communicate objectives both annually and monthly to ensure effective communication and coordination of all related activities between the Headquarters and Field Sales including regular contact with various internal functional areas (ie. Sales Management, Marketing Managers, Finance, Customer Service, etc.). Utilize understanding and knowledge of the dental market along with product expertise and selling skills/resources to assist in creating effective strategies and action plans to optimize sales results within the assigned region. Mentor other Sales Managers at various levels to develop best practices, high performance, and consistency throughout the sales team.

PRINCIPAL   ACTIVITIES/OBJECTIVES: 

  1. Develop, plan, coordinate and execute regional sales strategies into objectives and action plans for the existing product lines and all new product lines introduced. The incumbent will take into consideration geographical nuances along with A & B customer data, large group practice and dealer utilization as well in these plans.
  2. Train, co-travel, mentor, motivate, evaluate and effectively utilize Field Sales personnel within the territory to meet the sales objectives for the assigned region. Introduce new sales personnel to top Key Accounts, Dealer management, group practice management, and others to help infuse the new person into the territory
  3. Utilize support personnel and other resources of the Company to enhance outside partnerships and other organizational support for accomplishment of territory sales programs, objectives, and
  4. Directly manage and expand top key accounts, group practices and dealer management in the assigned region to maximize sales and customer Manage enrollment of trade and promotional programs and update specific key accounts on business plan strategies for win-win results. Evaluate and recommend additions to partnership and/or dealer networks, as applicable, that are consistent with Company’s strategies and objectives.
  5. Assist in developing, executing, and recommending changes to the Company’s sales policies and procedures including the Company’s annual promotional/trade
  6. Analyze, manage and interpret sell-through data for the assigned area to optimize sales, confirm that the Company’s sales results are representative of the market performance and evaluate the effectiveness of resource utilization (personnel, freight, value added funds, cost center spending, trade conventions, open houses, etc.). Recommend corrective action as
  7. Identify, monitor and review sales benchmarks/productivity measures reflective of the sales organization’s performance within the assigned region. Take corrective action as required to improve

 

 

  1. Responsible for operational budget targets for the region and those affected by the region ensuring cost control is being practiced by personnel with value added on each

 

1O. Maintain and comply with company policies and procedures as they apply to the position (ie. Scrap processing, money laundering, Code of Conduct, etc). Maintain proprietary information securely.

 

  1. Utilizes personnel resources and data systems to effectively cover identified schools/universities and high volume groups to maximize sales and influence leading opinion leaders within the assigned region.

 

 

NATURE AND SCOPE: 

The Regional Manager reports directly to the VP of Sales and is responsible for the generation of maximum sales growth from assigned accounts and personnel, effectively utilizing strategies, sales skills, personnel and available resources. This position is strategic, administrative, managerial, tactical, and technical as it requires complete understanding of dentistry, the dental market, large and small account management, sales planning, selling, networking, professional communication, conflict management, training, comparative/competitive selling techniques and broad supervisory and mentoring skills. The incumbent must be extremely motivated and active in the field in order to properly manage and grow a territory, train personnel, review and develop performance of oneself and others, communicate the Company’s objectives and translated action plans, while also maintaining personal contact with key account management and other decision makers in the region. This position is also responsible for all field sales personnel within the assigned region. This position is also responsible for all key accounts, large groups, and top dealer management within the region which includes, maintaining a relationship with key management, regular business plan updates with each, managing promotional/trade programs for these accounts and the assigned region, and analytical review and recommendations with updates on sales results and forward-looking goals to Sales Management and Headquarters regarding sales data. This position will also mentor other Sales Managers to improve overall Company performance.

 

 

KNOW-HOW: 

A BS degree is desirable or equivalent with a minimum of seven plus years of experience in the heathcare or relevant industry with a combination of front-line business to business proven sales results, small and large account management, and proven leadership and mentoring experience to meet the scope of the position. The incumbent must possess sound business judgment and be able to constantly analyze and enhance daily activities and action plans to maximize sales results. Advanced computer skills are required to analyze sales data and customize presentations and training tools. The incumbent must possess strong selling/negotiation skills, communication skills (oral and written) , and diplomacy to effectively lead and mentor as well as motivate direct reports, maintain a productive business relationship with accounts and influence internal management (Sales Administration , Marketing, Finance, and Customer Service). This position also requires strong sales planning and organizational skills plus the ability to conceptualize, evaluate, and interpret results of actions taken and create counter measures and enhanced action plans for themselves and others that they supervise. Knowledge of all federal regulations governing pricing and fair trade is essential.

 

 

 

 

 

 

PROBLEM-SOLVING:

 

Working under broadly defined objectives, policies, procedures and business plans, the incumbent is confronted with varied situations requiring strong evaluative, interpretive, creative, negotiating and interpersonal skills. The ability to identify, analyze, interpret and react to changing sales and industry trends is critical in order to ensure optimal sales and customer satisfaction within the assigned geographical region. Effective utilization of time, dollar, analytical data, and people resources is essential to maximize business gains in the Company’s position in the market place. Establishing reasonable and appropriate sales strategies, objectives, and communicating and mentoring on these are necessary to ensure sales budget accomplishment for the incumbent’s assigned area.

 

 

ACCOUNTABILITY: 

The Regional Manager is accountable for generating maximum sales volume of the Company’s product lines within the assigned geographic area and assigned team, as well as developing and maintaining viable working relationships with assigned dealers and large key accounts/practices. Given the national scope of some major accounts, the Manager’s ability to directly influence decisions effecting national sales based on decisions made can impact results beyond the limits of geography and assigned personnel and accounts. Implementation and achievement of sales goals and objectives rests with the incumbent. The Regional Manager is also accountable for the training, development and proper utilization of assigned employees to achieve these objectives as well as the most effective use of their time and dollar resources. The incumbent’s activities directly impact sales volume and the Company’s image and position in the market place both on a short term and long-term basis.

 

 

Sales Support Professional Parsippany NJ

Sales Support Professional

Contact to Hire

 

This position is responsible for supporting all aspects of the sales process and sales team.  This is a fast paced, multi-task oriented position.  Accuracy and the ability to change directions quickly are essential to success.  Must be very comfortable learning new computer software and have strong Excel, Power Point, Word and Outlook skills.

You will be responsible for using your creative marketing skills to organize power point presentations, assist with pricing models and research potential clients.

Ideal candidate will have an BA degree in business/sales and  1-3+yrs of working experience in a marketing environment.

This is a wonderful opportunity to use your marketing talents with excellent opportunity for advancement.

Resumes to: jobs@jobsbl.com

Node Developer Parsippany, NJ

Job Title: Developer  Programmer Analyst Node Developer

Client has an opening for a Developer to join our team to develop and maintain a variety of client/server

and web-based applications. You must be an experienced, goal-orientated, self-motivated team player

with the ability to work well in a small group. We value professionals that are mature, disciplined,

creative problem-solvers with a focus on results.

Position Responsibilities:

* Design, develop, test, debug and document programs that meet user needs and specifications

* Deliver high-quality systems and meet project deadlines

* Maintain and improve existing programs

* Gather, organize and manage information/requirements from users and various levels of

management

* Assist with ad-hoc reporting and special requests

* Work on a variety of projects (multi-task)

* Ability to quickly learn and work on new technologies

Must Have:

* .Net development – C#, ASP.Net, Visual Studio

*  SQL Server – TSQL, design

*Troubleshooting – debugging, problem solving

Forward Resume to: jobs@jobsbl.com along with desired salary

.NET Software Developer Rahway, NJ

.NET Software Developer Contract-to-Hire

For a logistics client located in Rahway, NJ area  is seeking a strong software programmer to join the information technology team to develop and maintain data processing applications and integrate with a 3rd party TMS package. Our primary application platforms utilize MS SQL Server 2008 R2, C#, ASP.net MVC, MSMQ, web services, and VBA for legacy applications.

Requirements:

– Minimum 5+ years of experience in the analysis, design, implementation and support of large complex applications (Winforms, WPF, or ASP.net MVC applications in C#).

– Strong knowledge of programming in T-SQL and LINQ.

– Ability to work independently and in conjunction with a team of developers.

– Ability to handle multiple projects and tasks, prioritize and organize effectively while paying attention to detail and accuracy.

– Preference will be shown toward candidates with experience developing applications using MSMQ and web services.

– Excellent analytical and communication skills (verbal and written).

– Relevant masters level degree preferred; B.S. in Computer Science

– Prior experience with transportation and logistics applications a plus

We welcome applicants seeking either a consultant role or full time employment.

forward resumes to: jobs@jobsbl.com along with salary expectations.

 

 

 

 

 

HR Generalist Bulter New Jersey

HR Generalist

Summary: While functioning as a generalist, main responsibilities are in the recruitment arena and administering policies relating to all phases of human resources by performing the following duties.

Job Duties:
• Manages the recruitment function by sourcing recruiting and interviewing applicants and employees to fill vacant positions. Provides feedback to managers regarding above.
• Handles all New Hire paperwork requirements.
• Maintains knowledge of legal requirements and government reporting regulations affecting human resources functions and ensures policies, procedures and reporting are in compliance.
• Responsible for Affirmative Action Plan and auditing of Affirmative Action Plan.
• Responsible for meeting Key Performance Standards set by the Company.
• Generates and maintains records of personnel data such as hires, promotions, transfers, performance reviews, and terminations, and employee statistics.
• Performs reference and background checks.
• Responsible for the Job Description process which includes maintaining and revising as needed.
• Shared responsibility with other members of the team for all training programs related to HR.
• Responsible for the Applicant Tracking System.
• Responsible for organizational charts and monthly reporting.
• Prepares employee separation, transfer and promotion notices and related documentation.
• Responds to inquires regarding policies, procedures and programs by interpreting company guidelines
• Assists with immigration issues.
• Assists in projects as needed.

Skills:
• To perform this job successfully, an individual should have knowledge of Database software; Human Resource systems; Internet software; Payroll systems; Spreadsheet software and Word Processing software.

Education & Requirements:
• Bachelor’s degree from four-year college or university required; and 3 to 5 years
related experience;
• PHR or SPHR preferred
• Valid drivers license required
• Up to 10% travel

Forward Resumes to: larson@jobsb.com

 

Quality Assurance Analyst Piscataway, NJ

Quality Assurance Analyst

 Job Summary: 

The overall purpose of this position is to ensure that quality software products are delivered. The incumbent in this position is primarily responsible for certification. on supported applications. He/She is expected to ensure all inadequacies in software, processes, or standards are brought to management attention for remediation. The role typically reports to a Manager, Quality Assurance.

Essential Functions:

Specific duties include but are not limited to:

  • Provide guidance and direction to project team, ensuring that proper QA procedures and practices are implemented.
  • Participate in requirements review; release planning, elaboration and sprint planning to understand requirements/user stories.
  • Ensure projects presented for Quality Assurance (QA) review contains properly documented test plans and follows defined methodology.
  • Assist project manager/ScrumMaster in development of project plans/sprint plans including time/cost estimates and deliverable dates.
  • Create test scenarios/test plans for any software and hardware upgrade. Distribute test plan to programmers, project manager/ScrumMaster and business team for their feedback. Update test plan to accommodate team’s suggestions. Ensure that test plans have covered all scenarios and user requirements are met.
  • Prepare QA tasks/test cases and execute them for Quality Assurance certification of projects.
  • Provide testing reports in status meetings.
  • Participate in technical design & code review to ensure that implementation is per requirements.
  • Implement, maintain, and run automated scripts using Ruby for regression testing and LoadRunner for performance testing.
  • Handle defect management using Jira/GreenHopper product.
  • Analyze defects, advice and recommend changes as necessary.

Qualifications

Education and Experience:

  • Bachelors or advanced degree in Computer Science, Business Administration, Mathematics or Engineering is required.
  • Minimum 5 years work experience in a software quality assurance field or in a software development related field. Minimum 2-3 years of experience in automation testing tools (QTP, Ruby) is required.

Skills & Other Requirements:

  • He/she must be a technologically savvy knowledge worker who seeks out technology solutions to business challenges.
  • Knowledge of testing techniques and development processes for Web applications.
  • Knowledge of automated testing tools is must.
  • Knowledge of project lifecycle for traditional waterfall and Scrum methodology is essential.
  • Strong knowledge of Ruby Language as well as RubyGems such as bundler, cucumber, headless, nokogiri is needed.
  • Must have experience with Behavior Driven Development (BDD or TDD).
  • Experience translating user stories to cucumber scenarios/features is required. Experience with integration test automation tools with Continuous integration tools such as Jenkins, Bamboo, cruisecontrol, travis CI and webdrivers (selenium/watir-webdriver) is a plus. Jmeter experience will be helpful. Must possess proficiency in English in order to convey technical problems to non-technical personnel.
  • Must be proficient in English reading, writing and presentation skills not only for communication purposes but also to read technical documents and to create test strategies and plans.
  • Must have the ability to deal effectively with people in contentious situations. Daily interaction with development staff and other QA team members is required.

Forward Resumes to: larson@jobsbl.com

 

Developer Programmer Analyst, Pearl River, New York

Job Description

Job Title: Developer  Programmer Analyst

Client has an opening for a Developer to join our team to develop and maintain a variety of client/server

and web-based applications. You must be an experienced, goal-orientated, self-motivated team player

with the ability to work well in a small group. We value professionals that are mature, disciplined,

creative problem-solvers with a focus on results.

Position Responsibilities:

* Design, develop, test, debug and document programs that meet user needs and specifications

* Deliver high-quality systems and meet project deadlines

* Maintain and improve existing programs

* Gather, organize and manage information/requirements from users and various levels of

management

* Assist with ad-hoc reporting and special requests

* Work on a variety of projects (multi-task)

* Ability to quickly learn and work on new technologies

Must Have:

* .Net development – C#, ASP.Net, Visual Studio

*  SQL Server – TSQL, design

*Troubleshooting – debugging, problem solving

* Integration – take disparate applications, data sources and get them to work together

* Ability to think “out-of-the-box”

* Passion for the jobtechnologies

* Good attention to detail and ability to produce work quickly, accurately, and

independently

* Must be able to take direction and execute instructions

* Ability to think analytically and complete projects with minimal supervision

?*Excellent prioritization, planning, organization, time management and multitasking

skills

Essential Skills:

  • Broad knowledge of Microsoft Technology Stack
  • Development experience with relational databases
  • Strong understanding of object oriented design and programming principles
  • Agile development methodology
  • QA and Testing Tools and Methodologies
  • Experience with Version Control – VSS, TFS
  • JavaScript, HTML
  • SSRS
  • LINQ

Bonus Skills

WPF

Entity Framework

SharePoint

Avectra netForum

Microsoft Dynamics GP

XSLT, XML, XPATH, XSD

jQuery, Ajax, Rest

CSS

SOAP,WCF

SSIS

Experience and Education

Minimum Bachelors in Computer Science or Information Systems or related field

At least 5 years of development experience

Lead, Technical Process Operations, Montvale New Jersey

Lead, Technical Process Operations

Essential Job Function: This position carries the responsibility for the direct client interface during the development; scale-up, transfer, and /or commercialization of products. This includes batch record creation, review, generation of DOE and sampling protocols, validation documents, authorship of final reports and technical project guidance to the client.

Expertise in fluid bed processing is highly sought as well as high shear granulation, drying, milling/sizing, compression, encapsulation, coating and packaging operations are fundamental requirements for the position.

This position is also accountable for the training and mentorship for junior personnel within the R&D, Technical Process Operations and Manufacturing Operations.  This position may require overnight travel accounting for 20% of your time.

This position is classified as a “safety sensitive” position especially in light of our formulation and development work with controlled substances and is therefore subject to random drug testing.

 General Information: Bachelor’s degree or equivalent Industry Standard Certification and +10 years related pharmaceutical experience. Position requires a demonstrated skill for scientific report writing, excellent verbal communication skills, and a customer oriented behaviors.

Responsibilities include but not limited to:

Direct client interface during the development, scale-up, transfer, and /or commercialization of products. This position has the oblicliention to meet or exceed the Client’s expectations set forth in the Statement of Work. This includes both the delivery of “hard” documents (DOE protocols, interim/final Product reports, validation documents, etc.) and driving major activities to meet project milestones and goals as stipulated in the Statement of Work.

  • Identification of critical scale-up and process validation parameters for each project, in close association with Technical Process Operations and Commercial manufacturing.
  •  Liaise with Business Development, Planning, QA, Contract Manufacturing, and Development on behalf of external client projects.
  •  Liaise with Business Development, Planning, QA, Contract Manufacturing, and Development on behalf of external client projects.
  • Provide guidance and mentoring to junior scientists and Technicians. Specific activities would include, 1) review of data summaries, 2) mechanical set-up, maintenance, and running of equipment, 3) cGMP and OSHA operating standards, 4) review of lab notebooks and process reports for completeness and accuracy.
  • Technical and process training to CM personnel as part of product transfers or new product introductions.
  • Ability to carry out complex work assignments in a high quality work environment.
  • Liaise with Project Manager for guidance and coordination of Development and Tech. Process supported activities.

 

  • Serve as a process technology expert for new unit operations installed in CLIENT’s laboratory as assigned. Activities include gaining an intimate scientific, mechanical, systems knowledge of these new processing systems.
  • Support Product Development/Formulations, Technical Services, and Business Development with client and CLIENT affiliated process transfers.
  • Assimilate R&D and Process Development product data to devise commercial scale processes which are validatable and cost effective.

Resumes to Larson@jobsbl.com

 

 

Medical Sales, Providence, RI Great Benefits

Category: Direct Hire Positions, General, Jobs

Posted on: January 16th, 2015

Location: Providence, RI

Salary: 50,000- 60,000 Base plus Commissions

Description:

Description:
Title: Territory Sales Manager Tampa Florida

Requirements: A BS degree or equivalent experience is desirable with a minimum of three years of proven sales experience within a business to business selling environment.

Individual must be a motivated, self-starter who can create a business plan for top customers in a territory to meet sales goals. The incumbent must be flexible in dealing with unusual situations and knowledgeable in techniques for creating, maintaining and developing strong customer relationships and sales.

Additional “know-how” for this position is acquired through an effective company administered sales training program or from direct in-depth work experience. Incumbent must demonstrate excellent sales planning, prioritization, selling, communication, research and learning, teaching, presentation, listening, interpersonal, conflict management, networking, relationship management, organizational, and time-management skills.

The incumbent must comfortably assume a leadership role among peers while assisting in their training/development and when serving as a convention coordinator. Strong computer skills are also a necessity with background in Microsoft products.

Duties: This position is responsible in working independently and setting territory and account management plans and actions in line with Company practices to meets established sales targets. The incumbent will coordinate and implement co-travels and training on Our Client products to distributors, distributor sales representatives, laboratories, group practices, general practitioners, dental personnel, schools, researchers and opinion leaders/lecturers.

Delivery of training includes co-travel with distributor representatives, one-on-one presentations, group presentations, sales meetings, and convention selling. Topics cover a wide range of areas including dental techniques, product applications, trouble-shooting, clinical/laboratory research, dental market trends, along with the use of competitive and comparative selling skills . Activities are carried out within assigned territory. Primary purpose is to influence and motivate customers to purchase and increase their use of Our Client products.

PRINCIPAL ACTIVITIES/OBJECTIVES:

1. Review territory, market, geographic, and customer data to plan and prioritize selling strategies and action plans for A&B Customers, large group practices, dealer management, and other top customers within the territory. 2. Continually research to have an on-gong comprehensive understanding of the Our Client products, dental market segments, competitor products, industry trends, dental techniques, new products, promotional activity and enhanced selling skills. 2. Arrange, facilitate, customize and execute training through group presentations to dentists, laboratory technicians, and other dental personnel by utilizing existing study clubs, dealer open houses, dental society meetings, customer lunch and learns, dental allied schools and by initiating co-sponsored seminars with laboratories and other Key Opinion Leaders. .

3. Identify and train opinion leaders, lecturers and university professors/researchers within assigned territory on the Division’s current products, new products, technical research data , new and existing technical application for the Division’s products and function as their primary contact with the Division. Coordinate activity, where applicable, with the Sales Manager, Marketing Managers, and Scientific Affairs Managers.

4. Function as a training resource on the Division’s products for all staff delivering dental services in a Managed Care or Alternative Care setting.

5. Create new user conversions as well as increase sales to current customer within the assigned territory by utilizing the Division’s sales automation and marketing services, dealer representatives, personal selling time, large clinics/laboratories, co-travels with dealer reps, written communication pieces, etc. Networking and motivation of dealer sales representatives and other Key Leaders in the territory is a critical aspect in realizing this objective. Direct calls made to core/select dentist and lab customers is also a critical aspect.

6. When detailed in the quarterly Sales Incentive Plan, fulfill the requested sales activities at schools within the assigned territory. Initiate the evaluation of the Division’s products in order to achieve staff acceptance of the product for use in university clinics.

7. Develop and maintain complete up-to-date records within the Company’s systems and processes, while also maintaining an adequate working inventory of literature, stock packages and promotional items.

8. Provide complete field reports, sales and marketing information, competitive activities, new product ideas, promotion improvements, technical inquiries. and required paperwork to the Sales Manager and Headquarters as assigned.

9. Control expenses within assigned budgets. Maintain and protect company property.

10. Follow Company practices, polices, and procedures to maintain compliance and integrity within the territory and customer base.

Resumes forward to larson@jobsbl.com