Microbiology Start Up Lab Consultant

Insight Global 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 contingent role 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

Key Responsibilities

SOP & Documentation Development

• Author, revise, and format GMP-compliant SOPs, work instructions, and forms supporting microbiology laboratory operations, including but not limited to:
• Instruments Performance Qualifications : Wrapper protocol for instruments validation, Calibrations and Preventative Maintenance Program, Equipment use monitoring and excursion handling, Autoclave use and cycle monitoring, Cleaning SOP for equipments, Performance Qualifications for equipments...
• Microbiological testing - USP 61, USP 62, USP 1231, Colony Counting and plate reading rules, Atypical Colonies/Suspected Objectionable - Escalation and ID decision tree, EM/PM for Finished product testing, Suitability testing for Finished products, Method Verification testing for finished products and water, Swab testing...
• Lab Functionality SOPs: Analyst Qualification and requalification, Good Microbiological Techniques and Contamination avoidance, Spill Response(Biohazard). Media QC program, Biohazard Waste Handling, Media preparation and handling, Aseptic techniques and gowning, Reagents, Diluents & Neutralizers – Prep/Labeling/Expiry, Sample Receipt, Chain of Custody, Storage & Disposal, Data Review, Second-Person Verification & Result Reporting...
• Ensure SOPs are aligned with applicable regulations and standards (e.g., FDA 21 CFR, EU GMP, USP, internal quality systems).

Laboratory Setup & Readiness Support

• Partner with laboratory leadership, Quality, Validation, and Operations teams to support GMP readiness activities.
• Assist in defining laboratory workflows and translating them into controlled documentation.
• Support document readiness for facility start-up, internal audits, and regulatory inspections.

Quality & Compliance Collaboration

• Ensure all documentation meets Ecolab formatting, document control, and change management requirements.
• Participate in document reviews, approvals, and controlled issuance processes.
• Support deviation investigations, CAPAs, and change controls related to laboratory procedures, as needed.

Training Support

• Assist with the creation of training materials based on newly developed SOPs.
• Support knowledge transfer and procedural training for laboratory personnel during lab onboarding and start-up phases.

Required Qualifications

• 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.

Preferred Qualifications

• 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).

Compensation:

$40-60/hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st 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.