GMP Microbiology Associate 1/2/Senior

Responsibilities

GMP and Compliance

• Works in a cGMP environment and ensures compliance with all regulatory and internal requirements
• Executes all activities in accordance with SOPs, batch records, and data integrity standards
  Maintains strong documentation practices aligned with GDP and cGMP expectations

Manufacturing Execution

• Performs bioconjugation and chemistry manufacturing operations
• Executes buffer preparation, material handling, filtration, and process steps per batch records
• Performs equipment and room setup, operation, and cleaning
• Supports manufacturing activities across multiple suites and processes
• Monitors process performance and escalates issues impacting safety, quality, or schedule

Microbiology Testing and Support

• Performs routine microbiological testing to support manufacturing operations
• Performs environmental monitoring (EM) support, including viable air and surface sampling as required
• Ensures proper handling, incubation, and documentation of microbiological samples
  Maintains chain of custody and traceability of all microbiological samples

Contamination Control

• Applies contamination control principles during all manufacturing and sampling activities
• Ensures proper cleaning and disinfection practices in manufacturing areas
• Identifies and escalates potential contamination risks or abnormal microbiological results
• Maintains awareness of facility and process conditions that may impact microbial control

Batch Release Support

• Supports batch release by completing and reviewing batch-related environmental monitoring forms and associated documentation
• Ensures accuracy, completeness, and traceability of EM data linked to each batch
• Coordinates with QA to ensure timely availability of microbiological and EM data
• Identifies gaps or discrepancies in EM documentation and escalates prior to batch disposition
  Supports compilation of manufacturing and microbiology data required for batch record review and release

Documentation and Quality Systems

• Completes batch records, EM related records, and logbooks accurately and in real time
• Initiates deviations and supports investigations, including microbiological events
• Provides input into CAPAs related to contamination or process performance
• Supports review and update of SOPs, batch records, and test methods

Equipment and Facility Support

• Supports operation and cleaning of manufacturing and microbiology-related equipment
• Performs routine maintenance support and troubleshooting activities

Collaboration

• Works cross-functionally with Quality Control, QA, MSAT, and Engineering
• Coordinates sample submission and testing timelines with QC or Qualified Vendor
• Communicates microbiological results that may impact manufacturing decisions

Training and Development

• Completes all required GMP and microbiology-related training
• Maintains qualification for manufacturing and microbiological testing activities
• Supports training of other associates as needed

Qualifications

• BS or MS in Microbiology, Biology, Biochemistry, or related field
• 0-3 years of experience in cGMP manufacturing
• Prior supervisory experience required
• Strong troubleshooting ability for process and equipment issues
• Ability to manage multiple priorities in a fast-paced environment
• Experience with Lean manufacturing or Six Sigma preferred

Physical Requirements

• Ability to stand or walk for extended periods
• Ability to lift up to 50 pounds
• Ability to work on the manufacturing floor for the duration of shift

FLSA: Non-Exempt