Job Description
One of our API Pharmaceutical Manufacturing clients is seeking a highly experienced GMP Microbiology Laboratory SOP Development Specialist to support the establishment and readiness of a GMP microbiology laboratory in King of Prussia, PA. This is a 3-month consulting role which is responsible for the development, authorship, and implementation of Standard Operating Procedures (SOPs) and associated documentation to ensure compliant laboratory operations aligned with current Good Manufacturing Practices (cGMP), quality standards, and regulatory expectations. The ideal candidate will have strong technical knowledge of microbiology laboratory operations and demonstrated experience writing clear, compliant SOPs for GMP-regulated environments. Key responsibilities include:
- SOP & Documentation Development
- Laboratory Setup & Readiness Support
- Quality & Compliance Collaboration
- Training Support
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Required Skills & Experience
- Bachelor’s degree in Microbiology, Biology, Life Sciences, or a related scientific discipline.
- Minimum of 5 years of experience in a GMP-regulated microbiology laboratory environment.
- Demonstrated experience authoring and implementing SOPs within GMP/Quality Systems.
- Strong working knowledge of microbiological testing methods and laboratory best practices.
- Familiarity with regulatory expectations (FDA, EU GMP, USP, ISO as applicable).
- Excellent technical writing, organizational, and communication skills.
- Ability to work independently in a fast-paced lab setup environment.
Nice to Have Skills & Experience
- Experience supporting new laboratory start-ups or facility expansions.
- Background in QA, Quality Systems, or compliance-related roles.
- Experience working as a consultant or contingent resource in regulated environments.
- Familiarity with electronic document management systems (EDMS).
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.