We are seeking an experienced QC Microbiology Team Lead to oversee all microbiological and sterility testing related to API testing. This role goes beyond laboratory operations and involves all activities affecting the microbial quality of our products including process validation cleaning validation method validation/transfer environmental monitoring aseptic manufacturing and critical site utilities.
Key Responsibilities:
Lead mentor and supervise the QC Microbiology team.
Implement and oversee methods procedures and evaluations for inspection and testing.
Monitor team performance provide feedback and identify opportunities for growth.
Communicate department objectives metrics and quality standards.
Supervise timely evaluation of complaints and returned products; initiate audits to ensure corrective actions are taken.
Review and approve nonconformances CAPAs change controls and QC investigations.
Provide input to quality control reports proposals and business opportunities.
Plan and oversee lab projects including method transfer optimization and equipment qualification.
Stay current with microbiological technology trends and regulatory requirements (FDA HPRA EMEA).
Requirements
Experience & Qualifications:
Level 8 degree in Microbiology or related scientific discipline.
Minimum 5 years experience in a QC Microbiology role including at least 3 years in pharmaceuticals.
12 years in a supervisory or team lead role.
Strong knowledge of microbiological testing techniques including sterility testing bioburden endotoxin environmental monitoring autoclave utilities testing and gamma irradiation.
Experience managing projects or leading teams.
Familiarity with regulatory requirements for pharmaceutical and aseptic products.
Required Skills:
Experience & Qualifications: Level 8 degree in Microbiology or related scientific discipline. Minimum 5 years experience in a QC Microbiology role including at least 3 years in pharmaceuticals. 12 years in a supervisory or team lead role. Strong knowledge of microbiological testing techniques including sterility testing bioburden endotoxin environmental monitoring autoclave utilities testing and gamma irradiation. Experience managing projects or leading teams. Familiarity with regulatory requirements for pharmaceutical and aseptic products.
We are seeking an experienced QC Microbiology Team Lead to oversee all microbiological and sterility testing related to API testing. This role goes beyond laboratory operations and involves all activities affecting the microbial quality of our products including process validation cleaning validatio...
We are seeking an experienced QC Microbiology Team Lead to oversee all microbiological and sterility testing related to API testing. This role goes beyond laboratory operations and involves all activities affecting the microbial quality of our products including process validation cleaning validation method validation/transfer environmental monitoring aseptic manufacturing and critical site utilities.
Key Responsibilities:
Lead mentor and supervise the QC Microbiology team.
Implement and oversee methods procedures and evaluations for inspection and testing.
Monitor team performance provide feedback and identify opportunities for growth.
Communicate department objectives metrics and quality standards.
Supervise timely evaluation of complaints and returned products; initiate audits to ensure corrective actions are taken.
Review and approve nonconformances CAPAs change controls and QC investigations.
Provide input to quality control reports proposals and business opportunities.
Plan and oversee lab projects including method transfer optimization and equipment qualification.
Stay current with microbiological technology trends and regulatory requirements (FDA HPRA EMEA).
Requirements
Experience & Qualifications:
Level 8 degree in Microbiology or related scientific discipline.
Minimum 5 years experience in a QC Microbiology role including at least 3 years in pharmaceuticals.
12 years in a supervisory or team lead role.
Strong knowledge of microbiological testing techniques including sterility testing bioburden endotoxin environmental monitoring autoclave utilities testing and gamma irradiation.
Experience managing projects or leading teams.
Familiarity with regulatory requirements for pharmaceutical and aseptic products.
Required Skills:
Experience & Qualifications: Level 8 degree in Microbiology or related scientific discipline. Minimum 5 years experience in a QC Microbiology role including at least 3 years in pharmaceuticals. 12 years in a supervisory or team lead role. Strong knowledge of microbiological testing techniques including sterility testing bioburden endotoxin environmental monitoring autoclave utilities testing and gamma irradiation. Experience managing projects or leading teams. Familiarity with regulatory requirements for pharmaceutical and aseptic products.
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