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
• 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.

• 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.

Last updated : 2024-05-05