Quality Specialist Job

QUALITY SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in San Diego, CA.

The Big Picture - Top Skills You Should Possess:~

- Quality Assurance
- Experience with ISO13485
- Project Management

What You'll Be Doing:

- 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.

What You Need to Bring to the Table:

- Minimum of three to five (3-5) years working within a regulated industry
- Experience with GxP production and process controls
- Must have experience working with electronic document management systems and enterprise resource systems and processes
- Must have excellent data evaluation skills and attention to detail
- Must be team oriented and have excellent communication skills
- Bonus Points! Otherwise Known As Preferred Qualifications:
- Project Management experience
- Experience with Oracle Agile and JD Edwards Enterprise One
- ISO 13485

What's In It For You?

- This is your chance to shine while supporting our client's dynamic Product Marketing, Communications and Business teams.

GET HIRED, APPLY NOW!

RECRUITER: Matthew Lillestol

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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