Quality Assurance Associate- (Quality)
Quality Assurance Associate- (Quality)
Englewood Lab
Totowa, NJ
See who Englewood Lab has hired for this role
Reports to: Quality Assurance Supervisor or Manager
Responsibilities:
Responsibilities:
- Conducts Annual Drug (Product) Reviews and Device History Reviews
- Maintains Regulatory Compliance documents and documents of external origin
- Maintain Document Control (including Records Retention)
- Participates in internal and external audit process.
- Participates in Mock (product) recall audits
- Maintain SOPs and Quality Forms as part of Document Control
- Maintains records of customer-approvals documents as evidence of authenticity
- Participate in QA Audits and draft reports of such audits.
- Effects changes to specification sheets as approved through change control requests
- Support Change Control program and maintain evidence of product and process changes
- Maintains SOP binders and updates such documents through approved CCs
- Supports EWL Employee training and documentation
- Maintains suppliers and vendors qualification program
- Supports and maintains approvals of formulary, specifications and manufacturing records
- Participates in Mock (product) recall audits
- Maintains Records Retention for QA Dept
- Initiates, Tracks, and authors Annual Drug Reviews (ADRs) for OTC and Annual Drug Reviews and Device History Reviews (DHRs)
- Assists in collating, reviewing, filing, maintaining of OTC bulk batch records, COAs, formula documents, etc
- Tracks and Performs physical sample retain review for ADRs and DHRs
- Tracks, Maintains, Closes requests for Change Control Notices (CC), Defective Material forms (DMF), and Deviations, Return Authorizations, Investigations, etc
- Minimum of 2 years of diploma program or 4-year college degree
- 2 to 3 years industry or related experience
- Previous experience in Pharma, Cosmetics, food, medical device, or allied profession
- Good Technical Writing ability
- Excellent knowledge of Word, Excel, Access, and other Windows-based programs
- Good record-keeping skills
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Non-profit Organizations and Primary and Secondary Education
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