Job Description

Job Summary:

The Quality Assurance (QA) Associate provides QA support at the floor operational level.

Responsible for support of manufacturing and testing operations related activities and review of associated documentation in support of material and product releases.

This role does NOT offer visa sponsorship or visa transfer (H1-B) for work authorization.


External applicants must be eligible to work in the US.

Essential Duties and Responsibilities:

1. To ensure that quality system requirements are effectively established and maintained.
2. Perform environmental monitoring of production areas and upload data into database. Maintain EM equipment and inventory
3. Perform line clearances of production areas and equipment.
4. Review and release incoming materials and perform reconciliation of completed raw material inventory cards.
5. Generation of product labelling used during manufacturing.
6. Control printed material generation, issuance and destruction of unallocated printed materials. Verify data and documentation to be utilized for printed material verification by Operations.
7. Ensure that the production records and testing results are complete, accurate and documented according to established written procedures by review and approval of Batch Records and Raw material Records for Release.
8. Ensure deviations from established procedures are documented per procedures.
9. Review, revise, edit and format Standard Operating Procedures, Logbooks, Specifications, Batch Records and other documentation according to written procedures.
10. Organizes and administers filing and archiving of all quality records and information including controlled substance tracking and audit records; does so consistent with LEAN 6S principles; assures records are retained consistent with Quality Agreements and appropriate regulatory requirements.
11. Ensure rejected raw materials and components are quarantined, properly identified and dispositioned appropriately.
12. Ensures that all products are manufactured in compliance with 21 CFR 211 or other applicable regulations.
13. Other duties as assigned.

Qualification Requirements:

• Bachelor's degree in Life Sciences or a related scientific field
• Minimum of three years' experience working in an FDA-regulated environment in Biologics, Pharmaceuticals, Medical Devices, or Tissue.
• Minimum one year working with Electronic Quality Management Systems such as Master Control, Documentum, Qualio, or Trackwise.
• Proficiency with technical writing and written and verbal communication.

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