Manufacturing Support Technologist Medical OEM

Website Berman Larson Kane

Best Medical Staffing since 1980

Manufacturing Support Technologist
City Booton
State NJ

Description The Manufacturing Support Technologist is responsible for managing product lifecycle of key products to include investigations, analysis, recommendations and implementation of product improvements. Specific tasks include: performing statistical data analysis of manufacturing process and QC data. Hands on activities in product improvement and development processes.

Essential Duties & Responsibilities:
• Perform product improvement and development activities to include pilot study setup, test studies, scale up manufacturing and product transfers.
• Perform statistical analysis for manufactured products, in-processes testing and final QC testing.
• Perform product support testing to supplement internal and external driven investigations.
• Work with QC Technologist to maintain and perform stability testing programs according to schedule.
• Perform QC and manufacturing document reviews.
• Develop validation documents (IQ,OQ,PQ) and perform validation as needed.
• Manage change control activities following design control guidelines.
• Work with RAQA and customers to address customer complaints and technical enquiries.
• Designated trainer and backup resource for QC testing and manufacturing.

• Knowledge of Spreadsheet software and Word Processing software.
• Ability to read and comprehend simple instructions, short correspondence, and
memos. Ability to write simple correspondence.
• Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
• Understanding of Design Control and New Product Development Activities.
• Full understanding of equipment and product validation process.

Education and/or Experience:
• Bachelor’s degree (B.S) from four-year college or university preferred; and two to
three years related experience and/or training in biotech company.
• MT (ASCP) preferred

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

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