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Supervisor, Plasma Quality Assurance
GrifolsQA Supervisor role at Grifols overseeing plasma inspection and release procedures. Leading compliance and quality assurance for plasma-derived medicines in healthcare.
ATS Keywords
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Hard Skills
Quality AssurancecGMPregulatory compliancedocumentation verificationdeviation investigationpolicy writinginternal auditsplasma operations monitoringtemperature documentation reviewplasma product quality acceptance
Soft Skills
analytical skillsorganizational skillsinterpersonal skillsproject leadershiptechnical leadershipsupervisory skillsmanagement skills
Industry Keywords
life sciencespharmaceuticalsCFRUSPEP PharmacopeiaICH GuidelinesISO GuidelinesSource Plasmaquality acceptanceplasma lot inspection
About the role
Key responsibilities & impact- Coordinate and supervise the 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 the quality acceptance and release of plasma product shipments
- Supervise daily activities of the quality assurance staff
- Ensure compliance with regulatory and customer requirements prior to release
- Review and verify temperature documentation
- Investigate and document deviations noted
- Participate in writing and revision of policies and procedures related to Source Plasma
- Monitor Plasma Operations for compliance
- Participate in internal audits
Requirements
What you’ll need- 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
Benefits
Comp & perks- Health insurance
- Flexible working hours
- Professional development opportunities
- Paid time off