Job Description :
Company Overview:

Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.

Our client, a leading developer, manufacturer and marketer of integrated systems for analysis of genetic variation and biological functions and serving customers at genomic research centers, clinical research organizations, biotechnology & pharmaceutical companies, seeks an accomplished Quality Specialist.

This position requires an individual who must work with minimal supervision to help facilitate the timely release of New Products and thorough quality review of batch records and associated documentation.
Individual will be part of project teams established for the improvement, creation, implementation and/or remediation of Quality systems, processes and procedures.
Execute product release activities including control, maintenance, review, and reconciliation of Device History Records (DHR
Ensure reagent lots meet QC functional test requirements; review data provided by QC or R&D prior to product release.
Release approved lots to inventory via materials resource software solution.
Facilitate initiation, review and closure of non-conformance records (NCRs) associated with production lots, including evaluation and disposition activities as needed.
Verify process deviations referenced in manufacturing batch records.
Coordinate with planning personnel to ensure timely release, consistent with Packaging/Shipping schedules. Prioritize review/release of products as needed.
Provide Good Documentation (GDP) and Use/Review of Device History Records (DHR) training and guidance to manufacturing personnel and new hires, consistent with the approved work instructions.
Ensure standard manufacturing and quality practices and procedures are followed.
Exercise judgment within defined practices and policies in selecting methods and techniques for obtaining solutions.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Bachelor''s Degree in science, engineering, or related field required.
Minimum of 3-5 years working within a regulated industry.
Experience with GxP production and process controls is a plus.
Experience with ISO13485 is a plus.
Must have experience working with electronic document management systems and enterprise resource systems and processes.
Experience with Oracle Agile and JD Edwards Enterprise One is a significant plus.
Must have excellent data evaluation skills and attention to detail.
Must be team oriented and have excellent communication skills.
Project Management skills and experience plus.
Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.

I''d love to talk to you if you think this position is right up your alley.

If you''re looking for rewarding employment and a company that puts its employees first, we''d like to work with you. We''re driven, people driven. We also offer group health Insurance (employee paid on a pre-tax basis

NOTE: “Candidates that are offered a position are required to pass pre-employment drug and background screening”