Quality Assurance Supervisor
Quality Assurance Supervisor
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Job Description
- Supports administrative function by:
o acting as the Deputy Quality Assurance Manager in their absence
o responsible for assigning Quality Assurance group tasks as workload requires
o responsible for supervising training of Quality Assurance group on assigned training requirement
o responsible for internal QA department documents
o primary contact for the PO system for the QA group
o monitoring Analytical Subcontractor compliance
o writing reviewing and approving Events CAPA OOS/OOT and Change Control
o managing investigations
o writing reviewing and conducting Quality System cGMP and GLP training
o participating in data analysis and reporting
o serving as QA trainer as needed
o supporting sister sites(s) as required
- Supports all Quality Assurance I II and III roles for:
o data reporting
o document control
o equipment control
- Supports Auditing by:
o performing Internal audits per Standard Operating Procedure
o supporting and hosting client and regulatory audits
o conducting external audits
- Supports Regulatory Compliance
- Supports the Stability Program as needed by:
o reviewing and approving Stability Protocols
o reviewing Stability Chamber Pull Schedules
o reviewing and approving Stability Chamber mapping
o monitoring and following up Stability Chamber excursions
- Supports Manufacturing as needed by:
o executing and reviewing batch records
o quality assurance inspection and release of cGMP materials
o reviewing creating and approving Master Batch Records
o reviewing creating and approving Certificates of Compliance
o conducting cGMP vendor qualification
- Other functions as assigned
Qualifications :
- At least 7 years of operations/QA experience in a GLP/GMP environment with at least three years in a QA role
- Minimum of a Bachelors Degree or Equivalent combination of education and experience.
- Understanding of FDA requirements and Quality Systems
- Must have good administrative skills and software skills (Microsoft Office Suite LIMS QMS)
Additional Information :
Position is full-time Monday - Friday 8am - 5pm . Candidates currently living within a commutable distance of Cary NC are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
