Senior Quality Assurance Associate
Senior Quality Assurance Associate
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Job Description
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
- 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
- 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)
- Supports Auditing by:
- Performing Internal audits per Standard Operating Procedure
- Supporting and hosting client and regulatory audits
- Conducting external audits
- Supports Regulatory Compliance
- 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
- 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
Qualifications :
Basic Minimum Qualifications:
- 10 years in a GMP/GLP environment with 7 years in a QA role
- Or 5 years of similar experience plus a Bachelors Degree in a scientific field
- Minimum of an Associates Degree
- Understanding of FDA requirements and Quality Systems
- Must have good administrative skills (Microsoft Office Suite LIMS QMS)
- Ability to work in the US for any company indefinitely without sponsorship
Additional Information :
Position is fulltime 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
