Quality assurance Jobs in Raleigh, NC

o acting as the Deputy Quality Assurance Manager in their absence

o responsible for assigning Quality Assurance group tasks as workload requires

o responsible for supervising training of Quality Assurance group on assigned training requirement

o responsible for internal QA department documents

o primary contact for the PO system for the QA group

o monitoring Analytical Subcontractor compliance

o writing reviewing and approving Events CAPA OOS / OOT and Change Control

o managing investigations

o writing reviewing and conducting Quality System cGMP and GLP training

o participating in data analysis and reporting

o serving as QA trainer as needed

o supporting sister sites(s) as required

• Supports all Quality Assurance I II and III roles for :

o data reporting

o document control

o equipment control

• Supports Auditing by :

o performing Internal audits per Standard Operating Procedure

o supporting and hosting client and regulatory audits

o conducting external audits

• Supports Regulatory Compliance
• Supports the Stability Program as needed by :

o reviewing and approving Stability Protocols

o reviewing Stability Chamber Pull Schedules

o reviewing and approving Stability Chamber mapping

o monitoring and following up Stability Chamber excursions

• Supports Manufacturing as needed by :

o executing and reviewing batch records

o quality assurance inspection and release of cGMP materials

o reviewing creating and approving Master Batch Records

o reviewing creating and approving Certificates of Compliance

o conducting cGMP vendor qualification

• Other functions as assigned

Qualifications :

• At least 7 years of operations / QA experience in a GLP / GMP environment with at least three years in a QA role
• Minimum of a Bachelors Degree or Equivalent combination of education and experience.
• Understanding of FDA requirements and Quality Systems
• Must have good administrative skills and software skills (Microsoft Office Suite LIMS QMS)

Additional Information :

Position is fulltime Monday Friday 8am 5pm . 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 USA BioPharma Services is a M / F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.

Remote Work : Employment Type :

Fulltime