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Catalent Pharma Solutions QA Operations Supervisor in Harmans, Maryland

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

QA Operations Supervisor

Position Summary

Catalent Cell and Gene Therapy is looking to recruit a QA Operations Supervisor to join our growing team in Harmans, MD.

QA Operations Supervisor is responsible for providing supervision for Quality Assurance On-the-Floor support, real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed.

This role has direct reports which include provide training, coaching and delegate job assignments as needed

This will be a 1st shift (7:00am-5pm) Monday through Friday position. Occasional weekend/on-call work may be needed based on manufacturing needs.

The Supervisor, QA Operations role is critical to our patients, the main responsibility is to provide QA oversight and support to client projects making sure the process and document records are in compliance with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!

The Role

  • Writes new standard operating procedures or revises existing documentation utilizing document management systems

  • Supports the evaluation and disposition of, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents

  • Supports the issuance and reconciliation of GMP documentation

  • Electronic system usage with tools such as Trackwise, Master Control, and QAD.

  • Reviews documented information from other functional area, reports abnormalities

  • Assists in the implementation of new processes.

  • Assists Value Stream Manager by assembling metrics as requested for their functional area.

  • Provides task-oriented training to Associates.

  • Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.

  • Represents QA on site committees such as SHE, tier meetings etc.

  • Reads, understands, and follows SOP’s and complies with cGMP’s

The Candidate

  • Minimum of a B.S. in a Life Sciences discipline

  • +6 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry

    • 2 years of Supervisory experience preferred
  • +4 years’ experience in Quality Assurance/Quality Control function/Manufacturing Operations

  • Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines

  • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

  • Exposure to Lean Operational Excellence highly desirable

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review & feedback process

  • Cross functional exposure to other areas of within the organization

  • Medical, Dental, Vision, and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

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 www.catalent.com/careers to explore career opportunities.

Catalent 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.

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.

Catalent 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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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