• QA Inspector II

    Catalent Pharma Solutions Philadelphia, PA 19133

    Job #2433496651

  • Catalent Pharma Solutions is Philadelphia, PA is hiring a QA Inspector II. This position reports to the Quality Supervisor. In addition to all of the requirements of the Quality Inspector, the Quality Inspector II will be able to work cross-functionally in IQA Inspection, Shipping/Distribution, and Label Control with limited to no supervision. Also, the Quality Inspector II will assist in identifying opportunities to improve processes, raise these to Quality Management and assist in the implementation and improvement of these processes, in partnership with Supply Chain personnel, Project Management, and Operations.

    This is a full-time role position: Monday - Friday, 1st shift 8:30am-5pm .

    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 ensuring that Standard Operating Procedures are consistently followed, and that cGMP's are observed, in the course of incoming inspection, distribution, label control, destruction and returns.

    • Verifies and inspects incoming materials and works accordingly with Quality and Project Management to handle any possible discrepancies.

    • Perform inspection and release of all clinical and commercial drug product and components received from customer or vendor as per customer specifications protocols and/or Catalent SOPs.

    • Perform inspection and release of all shipping and distribution materials to clinical sites or clients by reviewing all associated paperwork and picked material, including verification of each individual randomized container and compliance with customer specific distribution protocols.

    • Perform inspection and release of materials slated for destruction, by reviewing the associated paperwork and picked materials.

    • Inspect and release of clinical open, randomized, single panel booklet and multi-language labels produced by external vendors and Clinical Supply Services by comparison to approved label proof or label copy request.

    • Reviews BMS system printouts and chart recorder printouts for out of specification temperatures, humidity, and pressures.

    • Other duties as assigned.

    The Candidate

    • College degree preferred (BA, BS) or a minimum of 4 years of Logistics/Quality experience

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

    • Ability to quickly learn and implement QA Auditing techniques.

    • Good communication skills, both written and verbal

    • Strong interpersonal skills and is comfortable working in a team environment

    • Good Computer skills. Knowledge of MS Office and Inventory Management system are a plus.

    • Knowledge of the application of FDA cGMP's

    Why you should join Catalent:

    • Defined career path and annual performance review and feedback process

    • Diverse, inclusive culture

    • 19 days of PTO + 8 paid holidays

    • Several Employee Resource Groups focusing on D&I

    • Dynamic, fast-paced work environment

    • Employee Stock Purchase Program

    • 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 (~~~) 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.