- Quality Control Microbiology supports manufacturing activities at the Framingham Campus by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process.
- It aims to maintain a state of microbiological control in the Utility systems and within the environment where the manufacturing process is executed.
- It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.
location: Framingham, Massachusetts
job type: Contract
salary: $28.18 - 33.15 per hour
work hours: 7 to 3
- Contribute to general operations and testing of the QC Microbiological laboratory.
- Work independently under general supervision to conduct microbiological routine testing of environmental, critical utility, raw materials, in-process, validation samples and final products in accordance with SOPs and cGMP regulations.
- Review laboratory assay documentation for accuracy and timelines, evaluate preliminary results; aid in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.
- Collect and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; participate with the team to meet group goals and perform routine laboratory duties.
- Receipt of manufacturing samples into the QC lab as well as sample retain disposal
- Troubleshoot assay and instrument problems with Laboratory Supervisor
- Enter and review data in LIMS
- General maintenance of lab equipment
- Participate in writing and revising SOPs, protocols
- Maintain log books related to inventory and equipment
- Ensure labs are clean and safe (in compliance with cGMP)
- Participate in and perform special studies and projects assigned to QC Microbiology
- Perform ELISA testing
- Perform routine Quality Control testing of in-process and final products in a cGMP lab for release
- Perform other additional job related duties as required
- Practice safe work habits and adhere to company safety procedures and guidelines
- Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
- Bachelor's degree and a minimum of 2-4 years in Life Sciences discipline
- Working knowledge of Aseptic practices and technique
- 1 year experience in a cGMP lab environment
- Proficient in Outlook and MS Word and Excel and lab based data management systems
skills: Quality control, SOP, Microbiology, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.