Quality Control Analyst I
68 New York Ave, USMA0110 Framingham, MA
Quality Control Microbiology supports manufacturing activities at 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 environmental 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.
Contribute to general operations and testing of the QC Microbiology laboratory. Work independently and 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 timeliness, evaluation 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; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.
- Perform Water, Steam, and Critical Utility collection as well as associated testing.
- Perform Biological Indicator Testing.
- Perform Environmental Monitoring.
- Perform Endotoxin Testing (Gel Clot and Kinetic Turbidimetric).
- Perform Bioburden Testing of In-Process products, buffers, and water.
- Receive 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.
- Perform safety and operational lab audit.
- Perform general maintenance of lab equipment.
- Participate in writing and revisions SOPs, protocols.
- Assist in the development and optimization of testing methods.
- Maintain logbooks related to inventory and equipment.
- Ensure labs are clean and safe (in compliance with cGMP) and properly stocked.
- Make detailed observations in support of Alert, Action, and OOS result investigations.
- Participate in the qualification of equipment, methods, and processes.
- Participate and perform special studies & projects assigned to microbiology.
- Perform ELISA testing.
- Perform other additional job-related duties as required.
- Perform plate reading, streaking, gram staining, microbial identification.
- Perform routine Quality Control testing of in-process and final products in a cGMP lab for release.
- Practice safe work habits and adhere to safety procedures and guidelines.
- Provide training to less experienced staff.
- Participate in authoring complex and explicit documentation (protocols and technical reports)
- Involvement in equipment or facility qualifications (IQ/OQ/PQ) and method validation.
* Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
- Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make company a great place to work, and a company respected for the quality of its people and products.
- Action as a role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Associates degree in a related discipline and a minimum of 5 years industry experience or bachelor' s degree in Life Sciences discipline and a minimum of 2-4 years' experience.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.