Quality Assurance Associate II

4 weeks ago

Cary, United States Eurofins USA BioPharma Services Full time

Job Description

  • Supports all Quality Assurance I roles as required
  • Supports administrative function by:
  1. monitoring quality systems deadlines and reports to management pending and overdue activities
  2. assisting in Analytical Subcontractor documentation maintenance
  3. assisting with writing, reviewing, and approving Events, CAPA, OOS/OOT, and Change Control
  4. writing, reviewing, and conducting Quality System, cGMP, and GLP training as required
  • Supports Data Reporting by:
  1. reviewing, approving, and releasing laboratory data
  2. reviewing, creating, and approving Certificates of Analysis
  3. reviewing and approving Cumulative Reports, Protocols, Technical Reports and Summaries
  4. reviewing and approving Methods
  • Supports Document Control by:
  1. all Quality Assurance I roles
  2. maintaining all Master Lists
  3. maintaining Control of Specifications
  4. assisting with writing and approving internal documents
  • Supports Equipment Control by:
  1. maintaining identification and calibration labels/cards
  2. reviewing and approving of preventative maintenance, verification, calibration, and qualification
  3. maintaining records in LIMS
  4. induction and decommissioning
  • Supports Auditing by:
  1. performing Internal audits per Standard Operating Procedure
  2. supporting client and regulatory audits as needed
  • Supports Stability as needed by:
  1. reviewing and approving Stability Protocols
  2. reviewing Stability Chamber Pull Schedules
  3. reviewing and approving Stability Chamber mapping
  4. monitoring and following up Stability Chamber excursions
  • Supports Manufacturing as needed by:
  1. executing and reviewing batch records
  2. Quality Assurance inspection and release of cGMP materials
  • Other functions as assigned

Qualifications:
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.

  • 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.

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