Job Description

Manager, Quality Control (QC) Microbiology - Permanent - Philadelphia, PA

Proclinical is seeking a dedicated Quality Control Manager to oversee the daily operations of cGMP QC testing for drug products, focusing on lot release and stability.

Primary Responsibilities:

This role involves managing microbial testing, environmental monitoring, and supporting product stability programs. The successful candidate will also be responsible for authoring and reviewing quality control documents and leading investigations for out-of-specification results.

Skills & Requirements:

• Bachelor's degree in biological sciences or equivalent.
• Broad knowledge of biological drug development and quality control.
• Strong analytical, written, and verbal communication skills.
• Ability to manage multiple priorities and work under tight deadlines.
• Problem-solving skills with a proactive approach to challenges.
• Experience with cell therapy products is a plus.
• Ability to wear clean room attire and PPE, and perform physical tasks such as lifting up to 45 pounds.
• Comfortable working in both office and lab settings with potential exposure to chemicals and biohazards.

The Manager, Quality Control Microbiology's responsibilities will be:

• Oversee analysts in day-to-day QC testing and manage microbial testing at contract labs.
• Handle technical transfer, qualification, and validation of microbiology test methods.
• Manage the facility's environmental monitoring program.
• Author, review, and approve SOPs, protocols, reports, and specifications.
• Conduct trend analysis and generate reports for environmental monitoring data.
• Lead investigations for out-of-specification results and corrective actions.
• Support product stability programs and contamination control efforts.
• Maintain a microbial identification database for in-house isolates.
• Participate in site qualification, validation, and commissioning activities.
• Serve as a qualified trainer and support team career development.
• Establish positive relationships with internal and external partners.
• Solve technical issues related to GMP quality control efficiently.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonaldo at a.maldonaldo@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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