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Lead Quality Control Technician

Company: Catalent Pharma Solutions, Inc.
Location: Gaithersburg
Posted on: June 12, 2021

Job Description:

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

Catalent Gene Therapy is looking to hire a Lead Quality Control Technician to support our growing team in Gaithersburg, MD

The Lead Quality Control (QC) Technician is responsible for coordinating QC sample receipt, processing and testing from both our sites in Rockville and Gaithersburg to our contract testing laboratories (CTLs). This position will work closely with Manufacturing, Analytical and Process Development, as well as Project management for scheduling of sample submissions.

Please note this position will require travel between both sites.

The Lead QC Technician must demonstrate flexibility and reliability, technical knowledge, familiarity with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

Catalent, 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

  • Sample coordination and receipt from other departments for internal and external testing.
  • Manage the entry and tracking of reference standards and critical reagents associated to lots including the preparation of labels and label vials for samples & coordinate and execute sample transfer to various departments.
  • Schedule QC testing and activities.
  • Send out of test samples to Contract Testing Laboratories (CTL).
  • Follows up with CTLs on testing and turnaround times to ensure testing deadlines are met.
  • Effectively communicate trending of all CTL test results and updates.
  • Work closely with Manufacturing, Analytical Development and Process Development for scheduling of samples submission to the QC lab. May also interact with Project Managers on sample coordination.
  • Maintain flexibility in following unique campaign requirements that may include off-hour and weekend work.
  • Routinely pick up and process samples from the Rockville site.
  • Submit requisitions to buy laboratory supplies and for POs for CTLs.
  • Perform laboratory cleaning as part of routine work.

The Candidate

  • BS or AS in related discipline with 2+ Years of experience in a cGMP environment preferred
  • Biological sample coordination experience preferred
  • Prior experience with contract testing organizations preferred
  • Experience with Microsoft Excel and Microsoft Word.
  • Strong attention to detail and strong organizational skills.

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

Position Benefits:

  • 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.

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.

Keywords: Catalent Pharma Solutions, Inc., Washington DC , Lead Quality Control Technician, Other , Gaithersburg, DC

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