Quality Assurance Supervisor

Catalent Pharma Solutions; Pennsylvania; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

152 hours PTO + 8 paid holidays

Tuition Reimbursement

Medical, dental and vision benefits

Wellness programs

Job summary

Catalent Pharma Solutions in Philadelphia, PA, seeks an experienced QA professional to oversee incoming, distribution, and destruction audits and to ensure compliance with cGMP and GDP in a fast-paced production environment.

The role partners with Supply Chain and Operations, leading investigations, tracking metrics, and driving continuous improvement while aligning with regulatory requirements and company SOPs.

Qualifications

• HS Diploma/GED required with 5+ years of Production QA experience.
• College degree (BA/BS) preferred.
• Proven track record monitoring/auditing quality and identifying efficiencies in production.

Responsibilities

• Responsible for QA activities related to incoming, distribution and destruction and process auditing.
• Assist in ensuring quality and identity of pharmaceutical products during all aspects of incoming, distribution, or packaging processes.
• Act as Quality partner to support Supply Chain and Operations.
• Enforce Catalent policy and regulatory requirements.
• Act as site SME for Good Manufacturing Practices and Good Distribution Practices.
• Schedule daily resource plan to support Supply Chain/Operations activities.
• Lead investigations for compliance issues regarding incoming, distribution, returns, destruction, or packaging/production.
• Develop process excellence and efficiencies prior to project start.
• Track and report metrics and identify trends and predictive models.
• All other duties as assigned.

Skills

QA Auditing

Regulatory compliance

Leadership

Continuous improvement

MS Office

Education

HS Diploma/GED

BA/BS preferred

Tools

Inventory Management system

ERP systems

Reading engineering drawings

Job description

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.

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

Candidate Requirements

• 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

Additional Experience and Skills

• 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.

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 [e-mail] for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE. Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.