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    QC Training Specialist - Philadelphia, United States - Proclinical Staffing

    Proclinical Staffing
    Proclinical Staffing Philadelphia, United States

    2 weeks ago

    Default job background
    Permanent Engineering / Architecture
    Description

    QC Training Specialist - Permanent - Philadelphia, PA

    Proclinical is seeking a dedicated QC Training Specialist. This is a permanent position located in Philadelphia, PA.

    Primary Responsibilities:

    This role focuses on establishing a comprehensive training program and certification requirements for all Quality Control (QC) Teams. The successful candidate will be responsible for developing, conducting, and revising a QC training program, ensuring compliance with all relevant procedures, standards, and GMP regulations.

    Skills & Requirements:

    • Experience working in Biopharmaceutical or Pharmaceutical industry in Cell and/or Gene Therapy preferred.
    • Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
    • Minimum of 5-10 years of experience in biopharmaceutical based GMP operations.
    • Experience successfully working in an analytical role/level
    • Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
    • Solid understanding of Quality systems
    • Proficiency in basic and advanced analytical methodologies within a functional laboratory
    • Solid understanding and functional knowledge in Flow Cytometry, Microbiology assays, cell counts, and/or potency assays
    • Solid understanding and functional knowledge in Flow Cytometry, Microbiology assays, cell counts, and/or potency assays
    • Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
    • Experience, training, or certification with Process Excellence tools and methodologies
    • Experience with Quality Control document reviews and regulatory inspection processes
    • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
    • Proficiency with Microsoft Office Suite (Outlook, Excel, Word, and PowerPoint)
    • Requires ability and flexibility to work or support multiple shifts and provide occasional support on the weekends, as needed.
    • Ability to deal with ambiguity - ready to change gears and plans quickly, with the need to manage constant change.
    • Ability to work successfully in a fast-paced team-oriented environment.
    • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
    • Excellent oral and written communication skills. Strong technical writing ability required.

    The QC Training Specialist will:

    • Identify training needs, devise an organizational training strategy and curriculum, oversee its implementation, evaluates effectiveness through competency testing, and establish a feedback loop to ensure continuous improvement.
    • Develop a training schedule, coordinate the staffing and scheduling of in-house and field training.
    • Plan curriculum design and support documentation, including drafting and approval of SOPs.
    • Training and development of staff, including mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
    • Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
    • Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of training.
    • Establish key performance indicators to measure training effectiveness.
    • Create processes that enable timely and actionable performance feedback of trainees.
    • Develop a comprehensive understanding of current production process, as this role is viewed as a subject matter expert within specific area.
    • Ensure the department understands and complies with quality standards and requirements as documented.
    • Must adhere to our core values, policies, procedures, and business ethics.
    • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
    • Perform miscellaneous duties as assigned.

    If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) or .

    Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

    Proclinical Staffing is an equal opportunity employer.

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