CENW - Senior Microbiological QC Scientist - Selkirk Pharma

Описание: A Senior Microbiological Quality Control (QC) Scientist at a pharmaceutical company plays a crucial role in ensuring that products meet strict microbial quality standards. Here's a detailed job description typically associated with this role:

Job Title: Senior Microbiological Quality Control Scientist
Department: Quality Control / Microbiology
Reports to: QC Microbiology Manager or QC Director
Location: [Company Location]
Employment Type: Full-time

Job Summary:
The Senior Microbiological QC Scientist is responsible for overseeing microbiological testing and environmental monitoring to ensure the safety, sterility, and compliance of pharmaceutical products with regulatory standards. This role involves method development and validation, data analysis, deviation investigations, and supporting regulatory inspections. The senior scientist also mentors junior staff and contributes to continuous improvement initiatives within the QC Microbiology department.

Key Responsibilities:
Lead and perform microbiological testing, including but not limited to:

Bioburden and sterility testing
Endotoxin testing (e.g., LAL)
Microbial identification (e.g., MALDI-TOF, biochemical tests)
Environmental monitoring (air, surface, personnel)
Growth promotion and media suitability testing
Develop and validate microbiological methods according to compendial and regulatory guidelines (e.g., USP, EP, FDA, EMA).
Write, review, and approve protocols, reports, SOPs, and microbiology- related documentation.
Investigate microbiological deviations, out-of-specification results, and contamination events using root cause analysis tools.
Support regulatory audits and inspections by preparing documentation and representing QC Microbiology during walkthroughs or interviews.
Provide guidance and technical support to junior scientists and lab technicians.
Maintain laboratory equipment, ensure calibration, and manage lab supplies.
Participate in continuous improvement and risk assessment projects (e.g., aseptic practices, contamination control).
Collaborate cross-functionally with Manufacturing, QA, Regulatory Affairs, and R&D teams.

Qualifications:

Education: Bachelor's degree in Microbiology, Biology, or related life science field (Master’s or Ph.D. preferred).
Experience: Minimum 5–7 years of experience in a pharmaceutical microbiology QC lab, with at least 2 years in a senior or lead role.
Strong knowledge of GMP, USP 61, 62, 85, 71, 1116, and related global guidelines.
Hands-on experience with sterile and non-sterile product testing.
Experience with aseptic technique and cleanroom practices.
Familiarity with data integrity standards and electronic laboratory systems (e.g., LIMS, Empower).

Skills and Competencies:

Excellent analytical and problem-solving skills
Strong communication and leadership abilities
Detail-oriented with strong documentation practices
Capable of working independently and managing multiple priorities
Proficient in Microsoft Office and data analysis software

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