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Quality Control Lead Analyst (3rd Shift)

Company: Catalent
Location: Severn
Posted on: March 15, 2020

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

The Quality Control Lead Analyst (3rd Shift) is responsible for routine QC testing on cleaning, in-process and release samples. The QC Lead Analyst will also assist analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). This individual will be responsible for assisting with the monitoring of the day to day operations within the QC laboratory. The QC Lead Analyst must demonstrate strong technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

This is a third shift position that will reside roughly on a 12am-8am schedule and will report to the QC Supervisor at our Harmans/BWI site.

Paragon Gene Therapy, now a part of 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/Job Duties:

--- Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, ddPCR, HPLC, Capillary Electrophoresis, and Compendia.
--- Generate internal and external documents such as assay protocols, summary reports, and SOPs.
--- Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns.
--- Provide instrumentation care, maintenance, troubleshooting, and data interpretation.
--- Work on project teams developing and improving assays.
--- Work under general supervision to meet project goals.
--- Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured.
--- Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.

The Candidate

Experience & Education:

--- Bachelor in a Life Sciences discipline and 4 or more years of experience working in a QC laboratory (will consider reduced experience with increased levels of education in same field).
--- Considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.
--- Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.
--- Experience in writing SOPs and test methods as well as method qualification/validation documentation.
--- Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work.
--- Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks.
--- Ability to succeed in a team-oriented environment under very dynamic conditions.

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.

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, Severn , Quality Control Lead Analyst (3rd Shift), Professions , Severn, Maryland

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