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Reagent Associate (FDA Regulated)

Company: Actalent
Location: Ann Arbor
Posted on: September 21, 2022

Job Description:

Our client, a growing medical device corporation, is in need of adding three Reagent Associates to their growing team. The position is focused on adhering to FDA documentation along with working in a cleanroom focused on performing Reagent Assembly in accordance with Manufacturing Procedures (MPs), drawings and related Work Instructions (WKI). This position is GREAT for anyone looking to break into the medical device industry. Training is provided.7:30am - 4:00pm (Mon - Fri)Role and Responsibilities:--- Perform Reagent Assembly in accordance with Manufacturing Procedures (MPs), drawings and related Work Instructions (WKI).--- Prepare testing samples per Quality Testing (QT) procedures and instructions--- Carry out work in accordance with defined Quality Management System procedures, and support Quality initiatives.--- Support general Manufacturing objectives.--- Support systems development pilot production and experimental work orders, as required--- Assist in maintaining fixtures, assembly tools, assembly instrumentation and manufacturing job aids.--- Be committed to following and supporting safety practices.--- Prepares for production by reviewing work orders and production schedule, studying and clarifying specifications; calculating reagents and chemicals, as well as part requirements; collect materials and supplies. Set-up equipment necessary for different work orders.--- Documents production by completing applicable forms, reports, logs, and records equipment and batches using GDP practices.--- Keeps work areas clean and organized--- Maintain functional understanding of cGMP's and the impact of deviation from controlled processes and/or procedures. Participate in investigations as needed.--- Train/mentor less experienced and new operators.--- Maintain inventory; be familiar with Kan Ban, and FIFO. May be required to complete inventory counts periodically.Requirement:

  • Bachelor of Science + lab experience gained while earning the Bachelor's OR an Associate of Science/courses taken toward + 2 years of either laboratory experience, health care experience or working in a regulatory field.#LI-DL1

    About Actalent:

    Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
    The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Ann Arbor , Reagent Associate (FDA Regulated), Other , Ann Arbor, Michigan

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