Supervisor, Microbiology QC

Supervisor, Microbiology QC in Burlington, MA
Job Snapshot
- Employee Type: Full time
- Location: Burlington, MA (./search?city=Burlington)
- Job Type: Drug Discovery (./search?department=Drug Discovery)
- Experience: Not Specified
Job Description
Description
Supervisor, QC Microbiology in Burlington, MA AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Control Microbiologist Supervisor leads a team of 1st, 2nd, and 3rd shift QC Microbiologists and performs quality activities in support of product production and releases.
The QC Microbiologist Supervisor performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting and overseeing testing, trending, and reporting of results.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture. Responsibilities
• Supervise a team of Microbiologist in the Quality Control department (i.e. mentorship, training, scheduling)
• Organize workload and coordinate activities in order to ensure necessary production coverage across all shifts
• Mentorship and training of team members on applicable techniques and equipment
• Attend production/disposition meetings to represent QC Microbiology department
• Authoring/Review and revision of QC SOPs and test procedures
• Communicate effectively in both verbal and written form on results, issues, and plans
• Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMP as necessary
• Maintain Grade A/B gown qualification
• Perform routine inspections/walk-throughs of the cleanroom to monitor/refine aseptic practices/techniques
• Provide Support of general QC Microbiology Laboratory activities
• Perform/support microbiological testing (endotoxin, bioburden) for water
• Perform/support microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product
• Perform/support environmental monitoring of the cleanrooms (under ISO and EU specifications).
• Read, trend, and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results - draft final reports as required
• Review batch-specific environmental monitoring data in support of lot disposition activity
• Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests)
• Prepare and send out samples for microbiological identification
• Maintain historical files on organisms found in classified areas; microbial identification and trending
• Perform line clear and line start verifications
• Perform other microbiological assays: o
Sterility (including Biological Indicator testing) o
Growth promotion testing of all incoming media used in the microbiology laboratory. o
Microbial Limits testing
• QC microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure
• Initiate OOS/OOT
or Environmental Monitoring Excursion Investigations
• Investigation of OOS/OOT, Environmental Monitoring Excursion Investigations, and CAPA/Change Control Management o
Equipment cleaning and maintenance o
Maintaining supplies and inventory o
General laboratory housekeeping Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelor's Degree in Microbiology required; Advanced degree strongly preferred
• 5+ years' industry experience in a GMP, GLP, or pharmaceutical cleanroom environment; former supervisory experience a plus
• Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
• Strong organizational skills and the ability to prioritize/multitask
• Proficient in Microsoft Office Suite All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #LI-AC1
Qualifications
~
Job: Drug Discovery
Primary Location: Burlington, MA
Schedule: Full time
Shift Type: