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    Document Control Specialist - Stratford, United States - Actalent

    Actalent
    Actalent Stratford, United States

    Found in: SonicJobs Direct Apply US - 4 days ago

    Default job background
    Full time
    Description

    Seeking 1 Document Control Specialist

    Onsite in Stratford, CT

    Description:

    Pre-production preparation, review, and approval of batch records for various cGMP OTC, medical device, and pharmaceutical products

    Post-production batch record review and approval

    Review production data and draft COA and COC from this data using approved templates

    Trend data collected from batch records and update periodically

    Diagnose and propose areas of growth within current QMS

    Print, scan, file, and archive batch records and other quality documents

    Support the Director of Quality with quality-related activities

    Work smoothly within a devoted team

    Skills:

    qa/qc, batch record review, gmp, fda, pharmaceutical, medical device, coa, cmp, capa

    Additional Skills & Qualifications:

    Bachelor's degree in science related field (MS preferred)

    2+ years in like or similar function in pharmaceutical or medical device industry cgmp

    Strong communications skills and proficiency with the English language, specifically scientific, pharmaceutical, and medical device nomenclature

    Experience working in a cGMP environment

    Experience working with and familiarity with cGMP quality documentation such as batch records, NCRs, CAPAs, SOPs, DCRs, COAs, COCs, etc.,

    Knowledge of industry guidance and regulations from FDA, ICH, ISO, etc.,

    Experience with data review, compilation, and trending

    Strong editing skills

    Strong proficiency with Microsoft product suite

    Experience Level:

    Intermediate Level

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

    Diversity, Equity & Inclusion

    At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

    • Hiring diverse talent
    • Maintaining an inclusive environment through persistent self-reflection
    • Building a culture of care, engagement, and recognition with clear outcomes
    • Ensuring growth opportunities for our people

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.

    By applying, you consent to your information being transmitted by beBee to the Employer, as data controller, through the Employer's data processor SonicJobs.
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