Quality Assurance - Quality Systems Engineer
- Reviews and approves/confirms all new formulas in the Quality Systems.
- Design and author protocols and reports to support qualifications, validation and designs of experiments.
- Perform capability analysis and trending to support validation and qualifications.
- Co-ordinates process validation and product stability programs and maintain associated reports.
- Conducts Annual Drug Reviews and Device History Reviews.
- Maintains regulatory documents and all documents of external origin.
- Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods.
- Participates in internal and external audit process.
- Participates in product recall audits.
- Complies with 21 CFR Part 210, 211 & 820.Perform other duties as assigned by the manager.
- Perform Process Validation and Cleaning & Sanitization Validation under the quality systems to ensure compliance.
- Maintains formal drug stability program, bulk hold studies, and product compatibility by coordinating samples submission, testing, result retrieval and program review.
- Maintains files and database of customer-approvals and documents as evidence of authenticity.
- Effects changes to specification sheets as approved through proper change control requests.
- Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications.
- Maintains copies of approved change controls as applicable to product specification updates/revisions.
- Maintains SOP binders and updates such through approved CCs.
- Communicates new and updated SOPs to all employees at EWL.
- Maintain suppliers and vendors qualification program.
- Participate in IQOQ including Risk Assessment of Quality Systems.
- Perform annual drug and device history reviews.
- Any other special projects and duties at the discretion of the immediate supervisor.
- Associate’s degree (2-year college degree) required.
- Previous experience in Pharma, Cosmetics, food, medical device, or allied profession preferred.
- Good Technical Writing ability.
- Excellent knowledge of Word, Excel, Access, and other Windows-based programs.
- Good record-keeping skills.
- Knowledge of FDA Regulations under FD&C Act is a plus.
The approximate pay range for this position is $50,000 - $60,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities.
The benefit package includes:
- Medical, Dental, Vision, Life
- PTO
- Special Paid Leave for employees’ personal events
- Company Paid Holidays
- 401(k) employer match
- Year-End Gift
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