This position will work in the cGMP compliant QC Microbiology Laboratory supporting the manufacture of biological products. Responsibilities include performing and providing support for functional aspects of the facility such as environmental monitoring (EM), microbiological testing (bioburden, bacterial endotoxin testing, growth promotion, biological indicators, stock cultures), media fills, water testing, and validation support.
The incumbent will be expected to write and technically interpret controlled documents and reports, and review data produced by self and initiate investigations. Will interact with other departments to ensure that environmental monitoring scheduling and sample flow, are correctly maintained.
Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained. Will assist with qualifications (equipment, media, clean room, etc..). Will assist with Test Record and SOP revisions. Will assist in writing reports.
What will you do?
- Perform environmental monitoring of a biological production facility according to written procedures, while fully gowned, including operational monitoring and personnel monitoring during aseptic processing and filling.
- Oversee aliquoting/sterile filling operations and ensure acceptable aseptic techniques are employed on the floor.
- Qualify and perform microbiological testing such as bioburden, bacterial endotoxin and biological indicator testing
- Draft SOPs, Test Records, Qualification Protocols, OOS Environmental Investigations and Summary reports and any supporting documents (Reagent Preparations, Equipment SOPs etc)
- Review data EM data, analyze and summarize data with guidance.
- Order laboratory supplies and maintain required inventory according to SOPs
- Perform laboratory and equipment cleaning and preventive maintenance and calibration
- Read and report microbiological test results
- Perform Gram stains and arrange shipments of samples to contract labs for identification
- Maintains and ensures safe laboratory practices. Also drafts and reviews Job Hazard Analysis for assays.
- Other assigned duties could include sample logging and assisting with shipment preparations
Work performed would support GMP manufacturing activities and release testing. This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.