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Manager, Quality Control

Company: Catalent
Location: Chelsea
Posted on: November 18, 2022

Job Description:

Position Summary:

Catalent Pharma Solutions is hiring a Manager - Quality Control. This person will supervise the activities and associates of a quality control group in efforts to onboard new products and molecules, including instrument qualification and method transfer. The Manger - Quality Control will also be aware of how these activities relate to the release, stability, drug product characterization, provable acceptable range (PAR) studies, validation studies and other regulatory reportable testing activities.

This is a full time, salaried role, Monday - Friday - days.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent is committed to a Patient First culture through excellence in quality andcompliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

  • Maintains GMP compliance as related to the laboratories, equipment and staff.
  • Manage the installation and qualification of new laboratory equipment
  • Manage method transfers, as applicable.
  • Oversee the maintenance of equipment related data for trending, continuous improvement and application of effective preventative maintenance procedures.
  • Works closely with Analytical Development to ensure new and existing analytical methodologies are appropriately written and/or developed for use in the QC laboratory,
  • Trains others to independently execute QC test methods and practice all GMP related procedures.
  • Helps to maintain a database of QC data, as applicable, to observe trends, perform statistical analyses and/or define appropriate specifications and alert limits.
  • Understands regulatory requirements and their application as suitably scoped to either support early phase or late phase/commercial release and stability efforts.
  • Develops strategies to ensure effective achievement of objectives by delegating responsibilities and organizing work flows while monitoring and evaluating the completion of tasks and projects.
  • Collaborates with other senior associates to ensure consistent application of company policies and practices as well as promoting new policies and programs tactfully and authentically.
  • Helps to lead investigations relating to the QC laboratory as well as the applications of any corrective and preventative actions.
  • Ensures effective and efficient operations of the laboratory in terms of workflows, people flows, laboratory equipment, and staff training;
  • May participate in establishing Quality Agreements with contract laboratory as well as manage associated testing activities.
  • All other duties as assigned;

    The Candidate
    • Bachelor's Degree in Chemistry, Biology or related scientific field required. Master's degree in Chemistry, Biology or related scientific field preferred.
    • Minimum of five years of experience working in a cGMP regulated environment executing or overseeing Quality Control testing and related activities required. Prior supervisory and/or managerial experience required.
    • Experience in MDI/DPI analytical test methods preferred (i.e. Andersen Cascade Impactor and Emitted Dose Techniques) preferred.
    • Previous participation in regulatory audits preferred.
    • Thorough knowledge of HPLC, GC, FTIR and various other analytical techniques required.
    • Experience with statistical data analysis, DOE, HPLC software systems, trending analysis preferred.
    • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

      Why you should join Catalent:
      • Defined career path and annual performance review and feedback process
      • Diverse, inclusive culture
      • 19 days of PTO + 8 paid holidays
      • Dynamic, fast-paced work environment
      • Positive working environment focusing on continually improving processes to remain innovative
      • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
      • Competitive salary with quarterly bonus potential
      • Community engagement and green initiatives
      • Generous 401K matchand Paid Time Off accrual
      • Medical, dental and vision benefits effective day one of employment
      • Tuition Reimbursement
      • GymPass On-site fitness center and wellness programs
      • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
        Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

        Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

        personal initiative. dynamic pace. meaningful work.

        Visit Catalent Careers to explore career opportunities.

        Catalent is an Equal Opportunity Employer, including disability and veterans.

        If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

        Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

        Important Security Notice to U.S. Job Seekers:

        Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Keywords: Catalent, Chelsea , Manager, Quality Control, Executive , Chelsea, Massachusetts

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