What are the responsibilities and job description for the Quality Assurance Associate II position at Eurofins Humangenetik & Pränatal-Medizin?
Job Description
Required: a minimum of High School Diploma or Equivalent. Preferred Associate’s Degree and/or certifications in laboratory/quality/regulatory
Required: Understanding of FDA requirements and Quality Systems
Preferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Preferred: 1 – 2 Years in a laboratory environment.
Preferred: 3 years of GLP/GMP environment in laboratory operations or QA, or combination of both
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.
- Supports all Quality Assurance I roles as required
- Supports administrative function by:
- monitoring quality systems deadlines and reports to management pending and overdue activities
- assisting in Analytical Subcontractor documentation maintenance
- assisting with writing, reviewing, and approving Events, CAPA, OOS/OOT, and Change Control
- writing, reviewing, and conducting Quality System, cGMP, and GLP training as required
- Supports Data Reporting by:
- reviewing, approving, and releasing laboratory data
- reviewing, creating, and approving Certificates of Analysis
- reviewing and approving Cumulative Reports, Protocols, Technical Reports and Summaries
- reviewing and approving Methods
- Supports Document Control by:
- all Quality Assurance I roles
- maintaining all Master Lists
- maintaining Control of Specifications
- assisting with writing and approving internal documents
- Supports Equipment Control by:
- maintaining identification and calibration labels/cards
- reviewing and approving of preventative maintenance, verification, calibration, and qualification
- maintaining records in LIMS
- induction and decommissioning
- Supports Auditing by:
- performing Internal audits per Standard Operating Procedure
- supporting client and regulatory audits as needed
- Supports Stability as needed by:
- reviewing and approving Stability Protocols
- reviewing Stability Chamber Pull Schedules
- reviewing and approving Stability Chamber mapping
- monitoring and following up Stability Chamber excursions
- Supports Manufacturing as needed by:
- executing and reviewing batch records
- Quality Assurance inspection and release of cGMP materials
- Other functions as assigned
Required: a minimum of High School Diploma or Equivalent. Preferred Associate’s Degree and/or certifications in laboratory/quality/regulatory
Required: Understanding of FDA requirements and Quality Systems
Preferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Preferred: 1 – 2 Years in a laboratory environment.
Preferred: 3 years of GLP/GMP environment in laboratory operations or QA, or combination of both
Additional Information
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
