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Job Information

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.

Job Responsibilities

  • 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.

Qualifications

  • 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

Preferred Experience

  • 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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