Product Development Specialist Healthcare Parsippany NJ

Product Development Specialist
Description Summary: The Product Development Specialist 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.

Job Duties:
Perform product improvement and development activities to include pilot study setup, test studies, scale up manufacturing and product transfers.
Perform statistical analysis on manufacturing in processes testing and QC testing.
Perform product support testing to supplement internal and external driven investigations.
Maintain and perform stability testing program according to schedule.
Perform QC 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.

Education/Experience:
Bachelor’s degree (B.S) from four-year college or university preferred; and 2 to 3 years related experience and/or training in biotech company. MT (ASCP) certification preferred.

Skills:
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.
Knowledge of Spreadsheet software and Word Processing software.
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