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

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.