|Date Posted||June 2, 2021|
|Address||726 Heartland Trail, Suite 100|
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
Quality Assurance Associate – Operations
The Quality Assurance department is responsible for all quality assurance and quality control functions at Catalent, Madison. The Department’s primary function is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material, Master Cell Bank, and API release. The QA Operations Associate assures that all operations at Catalent meet or exceed cGMP regulations and client customer requirements. The QA Operations Associate assures the quality of Cell Banks and Bulk Drug Substance produced and supports release of BDS for further clinical manufacturing of drug product. This position also ensures quality of manufacturing and laboratory data and reports. This is accomplished by direct collaboration and oversight of Manufacturing Operations and Quality Control and the review/audit of data and reports as specified by Standard Operating Procedures.
This is a full time position. Shift is Monday – Friday, 8am – 430pm.
Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.
Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
- Serves as ‘Quality on the floor’ to assist and support manufacturing staff in detecting and solving compliance errors in real time.
- Audits GMP areas including during production.
- Reviews batch records, QC testing records, and all supporting records.
- Issues manufacturing batch records and labels.
- Reviews ancillary facility and equipment records in support of GMP operations.
- Reviews assay qualification, equipment, and stability protocols.
- Maintains effectiveness of the Quality System.
- Compiles complete batch records through collection of documentation from multiple sources (production, labs, etc.).
- Identifies and drives resolution of all documentation and batch record issues to allow for timely release.
- Assures the Cell Bank and Bulk Drug Substance are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
- Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science; OR
- Associate’s Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of two years’ related experience;
- Must have high attention to detail, the ability to work in a challenging, fast-paced environment, producing high quality work, all while adamantly adhering to SOPs and cGMPs;
- Must be computer proficient;
- Candidate must be open to assisting with rotating on call schedule to assist with weekend coverage;
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 19 days of paid time off annually + 8 paid holidays
- Competitive salary with yearly bonus potential
- Community engagement and green initiatives
- Generous 401K match and Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
- On-site fitness center and wellness programs
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