Senior Microbiology Manager – GMP QC Leader & QMS Expert

Penn Life Sciences, Inc.; Langhorne (Bucks County); In loco; USD 110.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) with company match

Health, vision, and dental Insurance

Childcare expense reimbursement

Tuition reimbursement

Annual bonus eligibility

Annual merit increases

Paid Time Off and Flexible Holidays

Descrizione del lavoro

Penn Life Sciences, Inc. in Langhorne, PA seeks a Microbiology Manager to act as SME and coordinate critical quality control projects, including MLT, bioburden, endotoxin, sterility testing, TAMC, and coliform detection. You will drive ISO-compliant testing and method validation in a regulated environment.

The role also requires maintaining QMS per 21 CFR Part 11, leading CAPA investigations, and supervising 5 microbiologists to ensure product quality and regulatory readiness.

Competenze

• Bachelor’s degree in Biological Sciences, Biochemistry, or Microbiology; 2 years experience.

Mansioni

• Lead SME for microbiological quality control projects (MLT, bioburden, endotoxin, sterility, TAMC, coliform detection).
• Perform method validation on BET for materials and finished products; conduct testing under ISO-5/6/7/8.
• Maintain QMS within Master Control; ensure 21 CFR Part 11 compliance and regulatory audits.
• Lead investigations and CAPA; supervise 5 microbiologists.

Conoscenze

BET

Bioburden testing

Aseptic processing

QMS

OOS/OOT

ISO-5/6/7/8

Vitek 2

Formazione

Bachelor’s degree in Biological Sciences

Strumenti

Vitek 2 analyzer

Descrizione del lavoro

Penn Life Sciences, Inc. in Langhorne, PA seeks a Microbiology Manager to act as SME and coordinate critical quality control projects, including MLT, bioburden, endotoxin, sterility testing, TAMC, and coliform detection. You will drive ISO-compliant testing and method validation in a regulated environment.

The role also requires maintaining QMS per 21 CFR Part 11, leading CAPA investigations, and supervising 5 microbiologists to ensure product quality and regulatory readiness.