Quality Assurance Supervisor
Catalent Inc
QA SupervisorPosition SummaryWork schedule: M-F 8am-5pm100% based on-site in Philadelphia, PACatalent'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 RoleResponsible for all QA activities related to incoming, distribution and destruction and process auditingAssist in ensuring the quality and identity of pharmaceutical products during all aspects of the incoming, distribution, or packaging processesAct as the Quality partner to support the Supply Chain and Operations departmentEnforce Catalent policy and regulatory requirementsAct 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 activitiesAct as lead investigator for all compliance issues regarding incoming, distribution, returns, destruction, or packaging/productionDevelop process excellence and efficiencies prior to the beginning of a projectTrack and report metrics and identify trends and predictive modelsAll other duties as assignedThe CandidateHS 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 advantageGood 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 CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePositive working environment focusing on continually improving processes to remain innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives152 hours of PTO + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentCommunity engagement and green initiativesGenerous 401K matchMedical, dental and vision benefitsTuition Reimbursement - Let us help you finish your degree or start a new degree!WellHub- program to promote overall physical wellnessPerkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent 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.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 View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.
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