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Supervisor, Extractables & Leachables

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    Skills

    • Analysis Skillsunmatched
    • Analytical Method Validationunmatched
    • Communication Skillsunmatched
    • Compensation and Benefitsunmatched
    • Continuous Improvementunmatched
    • Corporate Policiesunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Diversityunmatched
    • External Auditunmatched
    • Governmentunmatched
    • Healthcareunmatched
    • Heavy Liftingunmatched
    • ICPunmatched
    • Internal Auditunmatched
    • Laboratoryunmatched
    • Laboratory Managementunmatched
    • Laboratory Operationsunmatched
    • Laboratory Techniquesunmatched
    • Laboratory Testingunmatched
    • Lean Manufacturingunmatched
    • Learning Content Management Systems (LCMS)unmatched
    • Medical Productsunmatched
    • Mentoringunmatched
    • Metricsunmatched
    • Patient Careunmatched
    • People Managementunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Quality Assuranceunmatched
    • Quality Assurance Methodologyunmatched
    • Regulationsunmatched
    • Safety Processunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Sustainabilityunmatched
    • Team Playerunmatched
    • Willing to Travelunmatched

    Description

    This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.

    At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

    There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

    Job Summary

    The extractables & leachables supervisor is responsible for managing the day-to-day operations of the Extractables & Leachables analytical testing group.

    Essential Duties and Responsibilities

    • Supervise the day-to-day activities in the Extractables & Leachables group • Assure that analysts have been adequately trained for their role • Assist the Manager in proper management of resources of the group including analyst work assignments • Collect and evaluate metrics pertaining to operations • Implement continuous improvement/lean activities and events for the group • Assure compliance to West's Services and Solutions quality systems • Follow required cGMP regulations and internal QA procedures • Supervise and approve laboratory investigations to support internal and external customers • Supervise and implement the development and validation of numerous analytical techniques • Write, review, and approve documents such as laboratory investigations, work instructions, SOP's, etc. • Support internal and external audits • Participate in cross functional teams as laboratory operations leads to provide input and consultation for laboratory testing and projects • Hire new employees ensuring that their qualification and skills fit with the needs of the individual role • Develop competency with multiple complicated techniques, equipment, and/or test methods • Independently drive projects from initiation through completion • Mentor • Organize West material or technology focused studies and effectively communicate results • Lead communications with internal and external customers • Design and implement training strategies • Meet individual and departmental goals and metrics • Make rational and sound decisions at a program level • Adhere to established laboratory safety procedures • Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude

    Other duties as assigned.

    Education

    Bachelors Degree in relevant scientific field

    Work Experience

    Minimum 5 years in a directly related field and a cGMP environment A subject matter expert in directly relevant field Knowledge and/or hands on experience with a variety of analytical techniques including LCMS, GCMS, and ICP Preferred Knowledge, Skills and Abilities

    • cGMP Extractables & Leachables • Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description • Support and contribute to Lean Sigma programs and activities towards delivery of the set target • Previous supervisory experience

    Additional Requirements

    Job-related activities that require a physical activity such as standing in laboratory environment Effective dexterity to operate objects, tools, or controls and reach with hands and arms Employee may be required to lift heavy objects (up to 25 lbs.) without assistance Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)

    #LI-JJ1

    Travel Requirements

    5%: Up to 13 business days per year

    Physical Requirements

    Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

    West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

    If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.

    Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.

    Numbers & Facts

    LocationExton, PA
    IndustryBiotechnology/Pharmaceuticals
    Company Size100 to 499 employees
    Websitehttp://www.westpharma.com/

    About Company

    Leadership in Drug Administration Systems and Components Pharmaceutical, biopharmaceutical and medical device companies around the world rely on West Pharmaceutical Services, Inc. for standard-setting systems and device components for parenterally administered medicines.

    West applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics, vaccines and consumer healthcare products.

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