Supervisor, Quality Control (Microbiology) - 2nd Shift

Company: Catalent Pharma Solutions
Location: Severn
Posted on: February 23, 2021

Job Description:

Supervisor, Quality Control (Microbiology) - 2nd Shift Harmans, MD 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 The Supervisor, Quality Control (Microbiology) - 2nd Shift is responsible for effectively hiring, developing, coaching, counseling, managing and motivating the QC Microbiology staff. The Supervisor is responsible for the timely and accurate completion of required testing of Environmental Monitoring (EM)/ Clean Utilities, raw materials, in-process and finished products. They assure compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The Supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drive implementation in the laboratory. The Supervisor keeps laboratory management informed of all departmental activities and product related events. Position workweek is Monday through Friday (3pm-12am) and will reside at the Harmans/BWI campus. Catalent Cell and Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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. The Role:

• Supervises daily activities of QC Environmental Monitoring Analysts and assures that job activity deadlines are met on a timely basis.
• Hires and oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development.
• Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
• Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product.
• Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
• Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT).
• Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports. The Candidate:
  • B.S. in a Life Sciences discipline and 5-10 years of relevant and progressive experience working in Quality Control, with 1-2 years of supervisory experience.
  • Familiarity with Good Manufacturing Practices (cGMP's) and pharmacopeial compendia along with having experience in cGMP cleanrooms.
  • Have the knowledge and ability to apply advanced scientific and regulatory principles to solve operational, as well as routine quality tasks.
  • Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
  • Experience with viable and non-viable Environment Monitoring collection instruments, techniques and qualifications/validations.
  • Document writing, data interpretation, presentation, statistical analysis and trending a plus.--
  • Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team. We will identify candidates based on the following:
    • Leads with Integrity and Respect
    • Delivers Results
    • Demonstrates Business Acumen
    • Fosters Collaboration and Teamwork
    • Champions Change
    • Engages and Inspires
    • Coaches and Develops
    • Join a high growth and fast paced organization with a people focused culture
    • Global exposure, defined career path and annual performance review and feedback process
    • Competitive Medical, Dental, Vision and 401K 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. 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 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. Posted 13 Days Ago Full time 0050408 About Us Catalent = Catalyst + Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if---
      • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
      • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!
      • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
      • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
      • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
      • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here .--

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