Supervisor, Quality Assurance
Position Summary
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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. Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.
The QA Supervisor is responsible for providing leadership and Quality Assurance supervision support within Catalent’s Winchester site. This QA Supervisor will have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release and Change Controls.
Shift: 3rd (10 PM-6:30 AM)
The Role
Ensure Quality systems are compliant with corporate and site procedures as well as industry standards such as but not limited to Annual Product reviews, Complaints, Investigations and root cause analysis, Corrective and Preventive Actions, and Training.
Supervise the Quality Assurance Associates.
Function as the Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives.
Maintain positive employee relations, including problem resolution process.
Ensure the adherence to the standards of quality ruled by current cGMPs and the Company’s Quality Policies and site Standard Operating Procedures.
Author/review and ensure currency of SOPs related to the area of responsibility.
Propose, implement and enforce quality improvements.
Other duties as assigned.
The Candidate
BS in Science or related degree, or at least 7+ years of supervisory/management experience within the pharmaceutical or medical device industry with emphasis in Quality areas preferred.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
Exemplary oral and written communications skills.
Exemplary project management and organizational skills.
Working knowledge of cGMPs and regulations.
Prior supervisory/management experience.
File/Folder storage with non-repetitive light weight lifting, reaching and forward bending as necessary.
Infrequent lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.
Sustained sitting at desk or work station with use of phones, computers and any other office equipment required for specified position.
Static stance/standing as required.
Why You Should Join Catalent
Several Employee Resource Groups focusing on D&I
Employee Stock Purchase Program
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
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 Catalent Careers to explore career opportunities.
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.
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Winchester, Kentucky
Full Time