Writes/revises Standard Operating Procedures (SOPs), validation/qualification/verification protocols and reports for test methods. Leads method transfer/qualification/verification of test methods and instruments. Performs Risk Assessment for qualification of raw materials and drafts specifications. Identifies contract laboratories for outsourced test methods. Provides technical support on Analytical and Microbiology test methods for establishing the contract lab services, coordination for samp... more details
QC Specialist – Raw Materials
Summary:
The QC Specialist – Raw Materials candidate provides Quality Control support of all raw materials utilized in GMP Manufacturing of Cell Therapy products at our US Cell Therapy facility located in Princeton, NJ. As our QC Specialist – Raw Materials, you will be responsible for performing routine and specialized analytical/compendia testing of raw materials in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). The QC Specialist – Raw Materials is also responsible for working in a team atmosphere and meeting the needs of internal, as well as external customers. This candidate will support the inspection, sampling and batch record review of raw materials for clinical and commercial cell therapy products. Provides technical expertise on raw materials used in manufacturing and ensure materials are tested per specification in regards to compliance with quality policies, standards and procedures.
The Role:
- Writes/revises Standard Operating Procedures (SOPs), validation/qualification/verification protocols and reports for test methods.
- Leads method transfer/qualification/verification of test methods and instruments.
- Performs Risk Assessment for qualification of raw materials and drafts specifications.
- Identifies contract laboratories for outsourced test methods. Provides technical support on Analytical and Microbiology test methods for establishing the contract lab services, coordination for sample submissions and review data received from contract lab for cGMP compliance.
- Writes OOS (Out of Specification) /deviation investigations, change controls and CAPA.
- Perform inspection and sampling of raw materials, commercial and clinical biopharmaceutical products.
- Performs raw material assays to ensure results are passing in compliance to specification requirements.
- Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies. Maintains compliance with all required training.
- Review and provide Quality approval for electronic and paper incoming material receipt records, and GMP documentation such as work orders, investigation reports, deviation records, and other GMP records.
- Internal Quality Control support for creation and revision of GMP procedures including document review, approval, and archival.
- Alerts management of significant quality, compliance, supply, and safety risks.
- Participates as a QC team member process during regulatory inspections, third party audits, and internal audits.
The Candidate:
- Bachelor of Science in Life Science degree is required.
- 5+ years’ experience within the biologic, biopharmaceutical, or regulated industry.
- Experience in scientific laboratory and familiarity with basic instruments.
- Experience supporting raw material qualification and testing.
- Experience in writing procedures, protocols, and reports.
- Should possess knowledge of method validation and equipment qualification.
- Experience in GMP environment and is able to identify breach of cGMP principles and provide suggested corrective actions.
- Experience with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
- Knowledgeable and/or exposure to aseptic manufacturing processes including microbial and cell culture, and fill/finish.
- Must possess strong verbal, written, and oral communication skills.
- Must be able to work independently and with a team.
- Must possess problem-solving skills.
- Ability to recognize priorities and take action; make productive use of time.
Position Benefits:
- 152 hours PTO & 8 Holidays
- Medical, Dental & Vision Benefits and 401k
- Tuition Reimbursement
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.
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Catalent is an Equal Opportunity Employer, including disability and veterans.
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.
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