Quality Assurance Supervisor

Regulatory Toolkit; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

PTO + holidays

401K match

Medical, dental, vision benefits

Tuition Reimbursement

Job summary

Catalent's Philadelphia-site QA Supervisor role oversees incoming, distribution, and destruction QA activities, ensuring GMP compliance and product quality. You will partner with Supply Chain and Operations, lead investigations, and drive process improvements on a 100% on-site basis.

Ideal candidates have 5+ years in production QA, a regulated-field background, and supervisory experience, with strong MS Office and Lean Six Sigma familiarity. College degree preferred.

Qualifications

• HS Diploma/GED and 5+ years of Production QA experience required.
• College degree preferred (BA, BS).
• Experience in regulated field – pharma, food, automotive, etc.
• Proven track record of monitoring/auditing quality and identifying potential efficiencies.

Responsibilities

• Responsible for QA activities related to incoming, distribution and destruction and process auditing.
• Ensure quality and identity of pharmaceutical products during all packaging steps.
• Act as Quality partner to support Supply Chain and Operations.
• Lead investigations for compliance issues related to QA processes.
• Develop process excellence and efficiencies prior to project start.
• Track and report metrics and identify trends and predictive models.

Skills

QA auditing

Supervisory experience

Continuous improvement

FDA cGMP knowledge

MS Office proficiency

Lean Six Sigma knowledge

Education

HS Diploma/GED

BA/BS preferred

Tools

MS Office

Inventory Management system

Job description

QA Supervisor

Position Summary

• Work schedule: M-F 8am-5pm

• 100% based on-site in Philadelphia, PA

Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.

The Quality Assurance department is responsible for ensuring compliance with quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures. The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations.

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

• Enforce Catalent policy and regulatory requirements

• Act as site subject matter expert for "Good Manufacturing Practices" and "Good Distribution Practices"

• Work to schedule a daily resource plan to support Supply Chain/Operations activities

• 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

• All other duties as assigned

The Candidate

• HS Diploma/GED and 5+ years of Production QA experience required.

• College degree preferred (BA, BS)

• Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment.

• Previous supervisory experience of 5 years or more preferred.

• Experience in a regulated field – pharma, food, automotive, etc.

• Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.)

• 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 be on feet and move easily throughout the Operations facilities.

• Ability to quickly learn and implement QA Auditing techniques.

• Knowledge reading engineering drawings/material specifications, a plus.

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

• Be accessible to production floor, supply chain and office staff and to use required office equipment.

• Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

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 of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match

• Medical, dental and vision benefits

• 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.

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 [e-mail]. 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.