What are the responsibilities and job description for the Quality Assurance Associate II position at Eurofins USA BioPharma Services?
Job Description
- 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
Qualifications
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.
Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
