What are the responsibilities and job description for the QA System Specialist position at Engramec?
Job description:
Essential Job Responsibilities:
The Document Controls Specialist will be responsible for overseeing the administration and control of cGMP documents to ensure their accuracy, quality and integrity. Responsibilities include adhering to record retention policies, safeguarding information and retrieving data more effectively and efficiently.
Position Responsibilities
- Manage and maintain document control systems and databases
- Ensure all documents are properly stored and easily accessible
- Coordinate with various departments to ensure document accuracy and completeness
- Monitoring of SOPs revision stratus
- Review and update documents for accuracy and completeness
- Maintain records of document requests and retrievals
- Assist with documentation of non-conformances associated with deviations, CAPAs, investigations, customer complaints
- Ensure proper documentation retrieval for customer requests, certifications, regulatory etc.
- Maintain consistent and documented compliance will all relevant Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements
- Other job duties as required
Job Qualifications
- Must have great attendance.
- Two years’ experience in Quality Assurance or production preferably in the pharmaceutical and/or dietary supplements industry
- Strong organizational skills, excellent communication skills, and good attention to detail
- Basic understanding of CFR Part 111, and CFR Part 211 and GMP
- Must be able to read and understand English job instructions and safety requirements
Job Type: Full-time
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance