Supervisor, Quality Assurance - Operations
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.
The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging.
The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging.
On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.
Catalent Pharma Solutions is hiring a Supervisor, QA Operations who is responsible for supervising GMP Manufacturing Facility operations.
This individual supervises the work of QA Specialists and Senior QA Specialists on the Operations team.
This is a full-time salaried role.
The core hours are Monday - Friday 6:00AM - 2:30PM.
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.
The Role
* Oversight of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies;
* Oversight, review, and approval of Materials Management and Supply Chain activities;
* Oversight of the Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities;
* Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement;
* Initiation, review, approval, and trending of Discrepancies, including Deviations and Investigations;
* Support of implementation of CAPA and review of CAPA effectiveness as determined through Discrepancies.
Support review and implementation of Change Controls'
* Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods.
* Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials).
* Provide support during compliance inspections conducted by external sources (i.e.
health authorities).
* All other duties as assigned
The Candidate
* A Bachelor's degree in a scientific discipline is required, preferably in Physical Science or Chemistry;
* A minimum of 5 years of Quality Assurance experience in support of GMP production is required;
* Leadership experience preferred;
* Working knowledge of GMPs and their application to pharmaceutical manufacturing is required;
* Knowledge of FDA guidance documents is required;
* Previous exposure to investigations and product complaints is required;
* Ability to manage both day-to-day operations as well as project work in a fast-paced environment;
* 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
* Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
Why you should join Catalent:
* Defined career path and annual performance review and feedback process
* Diverse, inclusive culture
* Positive working environment focusing on continually improving processes to remain innovative
* Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
* 152 Hours + 8 paid holidays
* Several Employee Resource Groups focusing on D&I
* Dynamic, fast-paced work environment
* Community engagement and green initiatives
* Generous 401K match
* Company match on donations to organizations
* Medical, dental and vision benefits effective day one of employment
* Tuition Reimbursement - Let us help you finish your degree or start a new degree!
* WellHub program to promote overall physical wellness
* Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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 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 ******.
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 ****** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.