Sr Associate I, Quality Control Microbiology

Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours.

About This Role

We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned.

What You’ll Do

• Review test data in LIMS

• Prepare quarterly EM/UM reports

• Supports testing for all qualification and study directed testing

• Troubleshoot complex assays

• Perform microbiology testing (e.g. Bioburden, Endotoxin, plate reading, and microbial identification) following standard procedures

• Conduct routine Environmental Monitoring (viable and non-viable) in controlled manufacturing areas

• Collect and process utility and compressed gas samples

• Comply with SOPs and controlled documents under minimal supervision

• Maintain laboratory cleanliness, equipment readiness, and inventory

• Perform investigations (i.e. laboratory and deviations)

• Follow site safety and contamination control policies

• Work overtime as required by business needs

• Perform other assigned duties

Who You Are

• Someone who demonstrates strong attention to detail and analytical skills, along with a solid commitment to maintaining data integrity and quality

• You possess a collaborative approach and work effectively across manufacturing and facilities teams

Required Skills

• Bachelor’s in Microbiology, Biology, or related field

• Minimum 4 years’ experience in pharmaceutical microbiology and GMP-regulated manufacturing

• LIMS experience, including using electronic notebooks

• Demonstrated knowledge of microbiological assays (bioburden, endotoxin, environmental monitoring), aseptic techniques, and general laboratory techniques

• Experience with document control including reviewing and editing technical documents

• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results

• Able to follow procedures and complete technical tasks

• Can meet cleanroom and aseptic gowning requirements

• Physically able to stand long periods, bend, move carts, and lift 25 lbs

• Strong written and verbal communication skills, along with proficiency in Microsoft Word and Excel

• Excellent organizational skills with the ability to prioritize, follow through on tasks, and meet deadlines

Preferred Skills

• Advanced knowledge of Microbiology testing and Microbiology theory

• Prior experience in utilities monitoring, including gas monitoring

• Prior training experience, including classroom training

• Proficient in using LIMS systems, Veeva, Kneat, and Microsoft software

• Knowledgeable in GMP, GLP, and GDP requirements

• Advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)

• LEAN lab and Six Sigma training and/or certification

• Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)

• Experience performing EM/UM excursion investigations

 

Job Level: Professional

Additional Information

The base compensation range for this role is: $81,000.00-$105,000.00