Conduct routine and non-routine environmental monitoring of cGMP environments.
Perform sampling of utility systems and testing of in-process, drug substance (DS) and drug product (DP) release, and stability samples following Standard Operating Procedures (including Bioburden, Endotoxin, TOC, Nitrates, and Micro ID).
Execute peer reviews with minimal errors.
Maintain the lab, including general housekeeping, equipment monitoring and maintenance, and inventory of supplies.
Support data trending and assist with the compilation of trend reports.
Coordinate sample shipments to contract testing laboratories and review testing data reports as required.
Contribute to quality systems through support for non-conformances, deviations, corrective and preventive actions (CAPAs), investigations, Out OF Specifications (OOS), and change controls.
Revise SOPs and forms as necessary.
Maintain QC Microbiology-related systems in compliance with industry standards.
Flexibility to adapt work schedule based on business needs, including weekend and holiday operations.
Qualifications:
BA or BS in Microbiology or a related science.
1-2 years of laboratory experience in a QC testing capacity, ideally in a cGMP environment.
Ability to follow trained procedures and document work following cGMP/GDP/ALCOA+ guidelines. 1 year preferred
Knowledge of industry testing requirements and standards.
Proficiency in Bioburden and Endotoxin methods and analysis with 1 year experience preferred.
Computer skills, particularly with MS Word, Excel, and LIMS.
Strong communication and organizational skills, with the ability to work both independently and collaboratively.
