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Manufacturing Associate, Upstream I & II

Company: Randstad Life Sciences
Location: Milford
Posted on: May 12, 2022

Job Description:

Job Description Job Summary This position is focused on biologics manufacturing, which includes processing in upstream (cell culture) and downstream (purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply. Duties and Responsibilities Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities). Operate manufacturing process equipment to perform various manufacturing production steps Knowledge on initiating new revisions for procedures Proficient operating inside of a BSC, sampling, and performing with aseptic techniques. Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GMP/GDP guidelines. Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management softare. Order, receive and distribute supplies into production area as needed. Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers. Participate in (and may lead, as requested) team meetings and facilitate multidepartment discussions. Convey information to external stake holders (auditors, global colleagues, etc.). Provide support for groups that support manufacturing. Participate on Continuous Improvement Teams. May perform other duties as assigned. (During Production Processing these activities may increase) Manufacturing operations tasks requires operator to regularly remain on feet for shift. Pushing buffer containers ranging from 50L to 200L. Sitting for periods of 2 to 3 hours. Demonstrated knowledge of CGMP manufacturing. Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment. Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time. Able to read and follow detailed written instructions and have good verbal/written communication skills. Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms. Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.) Good computer skills, knowledge of Microsoft Word, Excel. Good interpersonal skills and be able to work effectively and efficiently in a team environment. Ability to meet schedule required; this position may include shift, weekend holiday work and overtime at times, as dictated by the 365-day per year production schedule. Ability to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment must be worn due to safety requirements. Such additional responsibilities as the Company may also assign. Qualifications Level I With high school diploma: Normally requires 0-3 years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred. With Bachelor---s degree: Normally requires 0-2 years of related experience. Good with Microsoft Office --- Outlook, Word, Excel. Level II With high school diploma: Normally requires 1-4 years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred. With Bachelor---s degree: Normally requires 0-2 years of related experience. Good with Microsoft Office --- Outlook, Word, Excel. Company Description Our business is supporting business productivity, from matching the right people with great jobs to custom project solutions and consulting. We use innovative technologies and a passion for people to provide you with the best experience possible.

Keywords: Randstad Life Sciences, Worcester , Manufacturing Associate, Upstream I & II, Other , Milford, Massachusetts

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