• Jt049 - MCS Manufacturing Associate

    Quality Consulting Group (Thousand Oaks, CA)


    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

    Responsibilities:

    +  1 year minimum GMP background manufacturing, computer savvy, SAP Knowledge is helpful as candidate will need to use Manufacturing Execution System. Experience with manual visual inspection

    + Under minimal supervision, performs manufacturing according to Standard Operating Procedure

    + Understand process parameters and can identify process anomalies

    +  Operate critical processing equipment

    +  Assist in ensuring operations are completed per manufacturing schedule

    +  Resource related to processing operations on the mfg. floor

    +  Responsible for identifying and communicating problems during operations

    +  Review, revise, and audit documents

    +  Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)

    +  Recognizes and escalates problems

    +  Able to establish working relationships with others outside area of expertise

    +  Ability and willingness to support flexible shift structure in support of operations (may include weekend)

    +  Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position

    +  Organizational skills and an ability to perform assignments with a high degree of attention to detail

    +  Written and oral communication skills.

    +  GMP knowledge with ability to interpret and apply applicable regulations

    +  Ability to understand analytical methods for manufacturing/laboratory area

    Qualifications:

    + High school/GED and 2 years work or military experience OR​ Associates and 6 months work or military experience​

    +  GMP experience/knowledge

    + Problem-solving and critical thinking

    + Adaptability and learning agility

    + Experience with manual visual inspection of drug product, analytical testing lab, or in a GMP regulated environment.

    + Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation

    + Knowledgeable of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)

    + Demonstrated ability to work in a team and professional environment.

    +  shift structure is 6am-3pm. Some training does require a start time of 5am.

     

    Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

     

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