ManpowerGroup Associate II, Quality Control in Boston, Massachusetts
Quality Control Microbiology Department supports manufacturing activities at Allston Landing 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.
This individual will report to the QC shift Supervisor in the Allston Quality Control laboratory and will contribute to general operations and testing of the QC Microbiology laboratory. QC Analyst II works independently with minimal supervision. Primary responsibilities include, but are not limited to the following: collect and process samples in a timely manner, microbiological routine testing of raw materials, in-process, validation samples and final products in accordance with SOPs and CGMP regulations, review laboratory assay documentation for accuracy and timeliness, participate with the team to meet group goals and perform routine laboratory duties.
The shift schedule is Wednesday - Saturday, from 6 AM - 4:30PM.
Perform Water, Steam and Critical Utility collection as well as associated testing
Perform Environmental Monitoring
Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric)
Perform Bioburden Testing of In-process products, buffers, and water
Biological Indicator Testing
Perform Growth Promotion Testing
Perform Plate Reading
Receipt of manufacturing samples into the QC lab as well as sample retain disposal
Autoclave QC micro equipment
Troubleshoot assay and instrument problems with Laboratory Supervisor
Enter and review data in LIMS
Conduct data analysis based on sample specification
Perform safety and operational lab audit
General maintenance of Lab equipment
Participate in writing and revising SOPs
Assist in the development and optimization of testing methods
Maintain log books 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
Performs other additional job related duties as required
Performing routine QC testing of in-process and final products in a CGMP lab for release.
Container closure testing, particulate testing, HACH, and plate streaking.
Provide training and technical leadership to less experienced staff.
Participate in authoring complex and explicit documentation (protocols and technical reports).
Involvement in equipment qualification (IQ, OQ, and PQs) and method validation.
Bachelor's Degree in Life Sciences discipline
Experience in a cGMP lab environment
Proficient in Outlook and MS Word and Excel and lab based data management systems
Experience with environmental monitoring including water testing
2 years experience in CGMP lab environment (1 year with Master's Degree in Life Sciences Discipline)
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
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