Senior QC Analyst - Microbiology

Proclinical Staffing; Philadelphia (Philadelphia County); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Senior QC Analyst to ensure top-tier quality standards in microbiological testing. This role involves performing critical cGMP testing, analyzing data for lot releases, and contributing to stability programs. Ideal candidates will have a strong background in pharmaceutical quality control, attention to detail, and the ability to manage multiple priorities effectively. Join a dynamic team dedicated to excellence in the life sciences sector, where your expertise will directly impact product quality and compliance.

Qualifications

• 5+ years of experience in pharmaceutical Quality Control.
• Extremely detail-oriented with strong technical skills.

Responsibilities

• Perform daily cGMP microbiological testing.
• Analyze data and report microbiology assay results.
• Generate and revise documentation such as SOPs and reports.

Skills

Biological Sciences

Pharmaceutical Quality Control

Technical Writing

Microbiological Testing

Attention to Detail

Team Collaboration

Time Management

GDP, GLP, GMP

Cell Therapy

Education

Bachelor's Degree in Biological Sciences

MSc. Degree (Preferred)

Job description

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Consultant/Client Lead at Proclinical Staffing

Senior QC Analyst, Microbiology - Permanent - Philadelphia PA

Join the team as a Senior QC Analyst and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

Primary Responsibilities:

This position supports quality control testing operations at our manufacturing site, focusing on in-process and final drug product microbial testing, including bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. The role may require working across shifts, including overtime, weekends, and holidays.

Skills & Requirements:

• Bachelor's degree in biological sciences or equivalent
• Minimum five (5) years of experience in pharmaceutical Quality Control
• Ability to interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skills
• Effective management of multiple priorities under tight timelines
• High ownership and accountability
• Sense of urgency and time sensitivity
• Experience with GDP, GLP, GMP preferred; MSc. degree preferred
• Cell therapy experience is a plus

Responsibilities:

• Perform daily cGMP microbiological testing at the iCTC facility
• Analyze data and report microbiology assay results supporting lot release
• Support investigations for out-of-specification results
• Assist with stability programs, including testing and data analysis
• Generate and revise documentation such as SOPs, protocols, reports, deviations, CAPAs, and change controls
• Peer review laboratory data and logbooks
• Contribute to team meetings and act as SME on assays
• Hands-on experience with environmental monitoring, endotoxins, sterility, and mycoplasma
• Proficient in technical writing
• Work in a cleanroom environment with biohazards and chemicals
• Comply with safety SOPs, SDS, and OSHA regulations

If interested, contact Jackie Cerchio at [e-mail]. To apply, click 'Apply' or request a callback at the top of the page.

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Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Analyst, Quality Assurance, and Science

Industries

• Professional Services