Microbiologist Documentation Specialist

Job Description

Job Title: Microbiology Documentation Specialist (Remote)

Position Summary:
The Microbiology Documentation Specialist is responsible for supporting microbiology quality and compliance activities within a pharmaceutical environment. This role focuses on authoring, reviewing, and maintaining controlled documentation while ensuring adherence to cGMP requirements and regulatory expectations. The specialist will work cross-functionally with Quality, Manufacturing, and Analytical teams to ensure timely completion of microbiological testing, documentation accuracy, and inspection readiness.

Key Responsibilities:

• Author, revise, and maintain microbiology-related SOPs, test methods, protocols, and reports in alignment with cGMP and 503B regulatory requirements.
• Review microbiological data and documentation for accuracy, completeness, and compliance (e.g., Environmental Monitoring, Personnel Monitoring, utilities, sterility, bioburden, endotoxin).
• Support batch release activities by ensuring all required microbiology testing and documentation are completed, reviewed, and approved within defined timelines.
• Lead and/or support investigations including OOS, OAL, OAC, and deviations.
• Initiate and manage Change Controls and CAPAs, impact assessments, and timely closure.
• Track microbiological testing schedules and ensure all required testing is performed within specified timeframes (e.g., incubation, sample hold times, stability timepoints)
• Collaborate with contract laboratories to ensure proper test execution, documentation, and data integrity.
• Ensure documentation practices follow ALCOA+ principles and internal GDP requirements.
• Support audit readiness and regulatory inspections by maintaining organized, accurate, and readily retrievable records.
• Provide guidance and support to internal teams on microbiology documentation and compliance expectations.

Qualifications:

• Bachelors degree in Microbiology, Biology, or related scientific field (Masters preferred)
• 10+ years of experience in pharmaceutical microbiology, preferably within a 503B outsourcing facility.
• , and environmental/personnel monitoring programs.
• Proven experience in writing and reviewing SOPs, protocols, and quality system documentation
• Hands-on experience with OOS investigations, CAPAs, Change Controls, and batch release processes
• Experience working with electronic QMS systems (e.g., MasterControl and Progen) preferred
• Strong attention to detail with excellent technical writing and review skills
• Ability to manage multiple priorities and meet tight deadlines in a fast-paced environment

Work Environment:

• Fully remote position
• Must be available during standard business hours aligned with U.S. Arizona time zones
• Occasional extended hours may be required to meet critical deadlines or support batch release timelines.

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