QC Supervisor

Catalent Pharma Solutions    Winchester, KY
Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Quality Control Supervisor

Position Summary

The Pharmaceutical Technician reports to the Quality Control Manager.

The QC Group Supervisor is responsible for supervising QC, Senior QC, and Principal QC Analysts and overseeing scheduling of all analytical functions to support manufacturing and quality agreement necessities for all scale up and commercial operations. Analysts at this level have demonstrated significant scientific and technical breadth to support analytical test methods in a pharmaceutical manufacturing facility. They also have demonstrated the ability and desire to supervise, train, coach and mentor other analysts. Individuals in this roll are very independent, well organized, and self-motivated and are expected to communicate effectively. Interaction with internal and external stakeholders and regulatory bodies will be commonplace.

Catalent s Winchester location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.

The Role

  • Supervise and provide day to day direction and support for 5 to 15 analysts, potentially across multiple shifts and functions (raw materials, in-process, finished goods, cleaning validations, or “project ). Will be responsible for annual performance reviews, performance feedback, coaching and any formal “personnel related items.
  • Supervise temporary employees, follow up on attendance and daily assigned tasks. Escalate issues to assure business continuity and timely course corrections.
  • Exhibit analytical mastery across all testing methodologies in the QC laboratory pertaining to pharmaceutical manufacturing and serve as mentors and coaches for individuals within the QC organization. Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (flame atomic absorption, polarimetry, loss on drying, heavy metal content and viscosity, etc.).
  • Coordinate scheduling of laboratory work and procedures to support manufacturing needs, i.e., raw materials, in-process, finished goods, cleaning validation, in process and stability testing along with management directed work. Effectively communicate work responsibilities and timelines to QC Analysts.
  • Communicate effectively and in a timely manner any issues and concerns (timeline, personnel, and operational related) to a QC Manager.
  • Effectively motivate analysts and keep work flow on track to meet or exceed customer’s timelines.
  • Lead and direct continuous improvement initiatives and project teams.

The Candidate

  • Bachelor’s Degree in Chemistry, Biology, Chemical Engineering or Life Sciences required (Advanced degree preferred)
  • 3+ Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role required
  • Prior supervisory experience preferred

Position Benefits

  • Potential for career growth within an expanding Winchester Site
  • Medical, Dental, Vision and 401K are all offered from day one of employment

Leadership Competencies for Performance and Development

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

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.

personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 [email protected] . 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.


Mon, 04 Nov 2019 22:50:23 GMT

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