Job Description

Scope of Function:

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 is a 2nd Shift role (4pm- 12am). This role does NOT offer visa sponsorship or visa transfer (HIB, OPT etc.) for work authorization. External applicants must be eligible to work in the US.

Reports to: QA Manager, Operations and Release

Specific Duties:

1. To ensure that quality system requirements are effectively established and maintained.
2. Perform environmental monitoring of production areas and upload data in to 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.

Education and Experience Required:

• 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.
• OR , In lieu of Batchelor’s Degree, 7 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

Skills:

Proficiency with technical writing and written and verbal communication.

Interacts with:

All TBI employees, clients, consultants, and global regulatory agencies.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

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