Quality Assurance Manager - Woonsocket, RI
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Key Areas of Responsibility include but are not limited to:
• Quality Control functions:
- In process Checks and Approvals, Finished product checks and approvals, Inspection of incoming materials, etc.
- Assist in processes such as equipment Validation / Qualification.
- Batch records and Lot Tracking documentation.
- Control of Label and Packaging Accountability
- Customer Reviews and Required Actions
- Sample Storage, Stability Organization, planning and documentation
- Establish work flow responsibilities, goals and prioritized action plans.
• Document Control System:
- Documentation and maintenance of Job descriptions, Standard Operating Procedures, Work Instructions, Controlled Records & Revision History
- Ensuring the system is organized, detailed, and adjustable with proper documentation
- Assist with Documentation of Controlled Records such as Change Control Reports, Corrective & Preventative Actions, Product Complaint Reviews and Actions, Risk Assessments & annual Product Reviews
• Quality System:
- Staying up-to-date with FDA regulations
- Extending and adding new processes/requirements to the Quality System as needed
- Ensure compliance with growing company
- Internal Auditing
- Training of GMP regulations
- The quality candidate should have a Bachelor's degree B.A. or equivalent business experience and 3+ years of progressively responsible experience in Quality Compliance, preferably Pharmaceutical regulations
- Excel, Word, PowerPoint
- Willingness to take initiative in the growth of the Quality System
- Ability to review regulations pertaining to the Company and generate requirements
- Effective verbal communication skills with a fluency in English
Keywords: Quality Assurance, Quality Assurance Manger, Quality Control
Full Time, Temp Position
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Quality Assurance Manager
City, State or Zip Code: Woonsocket, RI
Position Type: Full Time, Temp Position
Date Posted: 8/16/2018