Catalent Pharma Solutions

QA Supervisor

Position Summary

Catalent Pharma Solutions in Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will provide Quality Assurance support for the Quality Inspectors on the production floor, incoming material quality, and/or distribution quality, including quality oversight for material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will provide customer satisfaction and operational efficiency.

This is a full-time position: Monday – Friday, days.

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.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

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:

• Responsible for all QA activities related to incoming, distribution and destruction and process auditing

• Assist in ensuring the quality and identity of pharmaceutical products during all aspects of the incoming, distribution, or packaging processes

• Act as the Quality partner to support the Supply Chain and Operations department. Act as site subject matter expert for "Good Manufacturing Practices" and "Good Distribution Practices"

• Act as lead investigator for all compliance issues regarding incoming, distribution, returns, destruction, or packaging/production

• Develop process excellence and efficiencies prior to the beginning of a project; Track and report metrics and identify trends and predictive models

• Review and revise SOPs/Forms, Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory, and customer requirements

• Support Corporate and local Quality policies and initiatives. Support compliance for USDA, HHS, state, and foreign regulatory bodies

• Anticipates internal and or external business challenges and/or regulatory Issues; recommends process, product or service Improvements

• Perform all related duties and/or other functions as required

The Candidate:

• High school diploma or general education diploma is required

• College degree is preferred

• Minimum of 5 years in a Pharmaceutical or Medical industry is required

• Previous Supervisory experience is preferred

• Good computer skills, knowledge of MS Office and Inventory Management system are a plus

• Basic knowledge of Lean Six Sigma methodologies an advantage. Good knowledge of the application of FDA cGMP’s

• Ability to quickly learn and implement QA Auditing techniques

• Knowledge reading engineering drawing/material specification, a plus

• Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-15 pounds

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• 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

• Competitive salary with possible 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 – Let us help you finish your degree or earn a new one!

• GymPass 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.

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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .