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 Raw Materials Coordinator is responsible for the coordination and delivery of raw material test samples internally and to Contract Laboratories in a GMP environment.
Position workweek is Monday through Friday (8am-5pm) and will reside at the BioPark campus.
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:
Sampling of raw materials according to established specifications.
Coordinate and delivery of samples to QC lab for internal testing of raw materials.
Sending out of raw material samples to Contract Testing Laboratories (CTL).
Follows up with CTLs on testing and turnaround times to ensure testing deadlines are met.
Review of test data from CTLs. Includes interpretation of test results according to specifications, USP and EP.
Works closely with Quality Control and Material Control for coordination of raw materials for sampling and testing. May also interact with Project Managers on raw material coordination.
Establishes and revises material specifications in accordance with current compendial chapters/monographs and updates as well as client specific requests.
Experience & Education:
B.S. or A.S. in a Life Sciences discipline preferred and 2-4 years of relevant experience working in a cGMP environment.
Experience working in cGMP Quality Control, working with raw material testing and set up of raw material programs and experience with USP and EP.
Flexibility in following unique campaign requirements that may include off-hour and weekend work.
Strong attention to detail and strong organizational skills. Strong verbal communication skills with outside contract laboratories.
Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
Ability to succeed in a team-oriented environment under very dynamic conditions.
Ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
Experience with CTLs and coordination of sample testing.
We will identify candidates based on the following:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
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.
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.