Supervisor, Plasma Quality Assurance – 2nd Shift
Grifols
full-time
Posted on:
Location Type: Office
Location: Clayton • North Carolina • United States
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About the role
- Coordinate and supervise inspection and release of plasma lots for sale or further manufacture
- Verify critical systems and documentation associated with the destruction of plasma
- Ensure compliance to approved procedures
- Responsible for quality acceptance and release of plasma product shipments and supervision of daily activities of quality assurance staff
- Supervise daily activities related to receipt, storage, processing of Lookback Alerts, quarantine of unsuitable units, and release of Source Plasma
- Review and verify temperature documentation to ensure conformance to appropriate temperature specifications
- Investigate and document deviations noted from compliance reviews, audits and customer complaints
- Participate in writing and revising policies and procedures related to Source Plasma
- Monitor Plasma Operations for compliance with regulations, cGMPs and CFRs
- Participate in internal audit for the facility
- Interface with multiple management levels and support/service groups internally and externally
- Train current and new employees and maintain/update training records of QA staff
- Supervise activities of quality assurance staff including hiring, performance management, and professional development
- Monitor department costs to meet QA and company financial objectives
Requirements
- Bachelor’s degree in life sciences or related field ideal
- Minimum of 5 years of Quality Assurance related experience
- 3 years working in pharmaceuticals
- Project or technical leadership experience required
- Supervisory or management experience preferred
- Strong analytical, organizational and interpersonal skills
- Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines
- Excellent written/verbal/leadership skills
- Ability to make sound decisions that may affect the quality purity or efficacy or a drug product
- Anticipates and identifies problems; analyzes situations; consider alternatives; monitor and evaluates results in a systematic manner.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancecompliance reviewstemperature documentationdeviation investigationpolicy writinginternal auditingtraining and developmentperformance managementproject leadershiptechnical leadership
Soft Skills
analytical skillsorganizational skillsinterpersonal skillswritten communicationverbal communicationleadership skillsdecision makingproblem solvingsystematic evaluationteam supervision