Supervisor, Quality Assurance Operations - Allentown - Germer International - Pharmaceutical Recruiting

    Germer International - Pharmaceutical Recruiting
    Germer International - Pharmaceutical Recruiting Allentown

    1 week ago

    Pharmaceutical / Bio-tech
    Description

    Quality Assurance Operations Supervisor

    Essential Duties and Responsibilities

    • Overall responsibility for coordinating the disposition of API and drug product
    • Coordinates batch documentation review with Operations groups to ensure GMP compliance and timely delivery of products to customers
    • Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements
    • Supervises day-to-day functions of the QA Operations team
    • Mentors/coaches and provides succession planning for direct reports
    • Ensures batches meet GMP requirements and all production and QC documentation has been reviewed prior to disposition
    • If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures.
    • Ensures QC data meets specifications and any OOSs are investigated per internal procedures
    • Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance
    • Works with global partners in EU/UK QA to ensure batches are dispositioned and records provided in a timely manner
    • Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs
    • Prepares metrics for weekly, monthly and quarterly Management meetings

    Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e.

    • Critical Thinking skills using "Risk Based" logic and reasoning to identify the strengths and weaknesses in QMS, recommend and institute solutions, conclusions, and approaches to problems
    • Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches
    • Attention to detail/ sense of urgency- ability to act quickly and escalate issues
    • Excellent customer service skills and professional demeanor always to interface effectively with all internal and external customers
    • Excellent verbal and written communication skills
    • Energetic, enthusiastic, and motivational disposition

    Education/Experience

    • Bachelor's degree required with Bachelor of Science preferred
    • 5+ years' experience in Pharmaceutical/Biotech industry
    • Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS
    • Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.

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