The Senior Quality Assurance Associate is responsible for administrative function, data reporting, document control, equipment control, auditing, regulatory compliance, stability, and manufacturing activities as needed.
- Start and stop work authority
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Supports admininistration function by:
- Acting as the Deputy QAS/QAM in their absence
- Monitoring quality systems deadlines and reports to management pending and overdue activities
- Assisting with the PO system for the QA group o maintaining Analytical Subcontractor compliance
- Writing, reviewing, and approving Events, CAPA, OOS/OOT and Change Control
- Managing investigations
- Writing, reviewing, and conducting Quality System, cGMP, and GLP training
- Participating in data analysis and reporting
- Serving as QA trainer, as needed
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Supporting sister sites(s) as required
- Supports all Quality Assurance I and II roles for:
- Auditing
- Data reporting
- Document control
- Equipment control
- Manufacturing (as required)
- Stability (as required)
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Supports Auditing by:
- Performing Internal audits per Standard Operating Procedure
- Supporting and hosting client and regulatory audits
- Conducting external audits
- Supports Regulatory Compliance
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Supports the Stability Program as needed by:
- Reviewing and approving Stability Protocols
- Reviewing Stability Chamber Pull Schedules
- Reviewing and approving Stability Chamber mapping o monitoring and following up Stability Chamber excursions o other task as required
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Supports Manufacturing as needed by:
- Executing and reviewing batch records
- Quality assurance inspection and release of cGMP materials o reviewing, creating, and approving Batch Records
- Reviewing, creating, and approving Certificates of Compliance
- Conducting cGMP vendor qualification
- Other functions as assigned
- Required: 10+ years in a GMP/GLP environment with 7+ years in a QA role
Required: Minimum of an Associate’s Degree
Required: Understanding of FDA requirements and Quality Systems
Required: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Preferred: Bachelor’s Degree in a scientific field
Position is full-time, Monday - Friday 8:00am - 5:00pm . 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
