QA Inspector

Catalent; Philadelphia (Philadelphia County); On-site; USD 50,000 - 80,000; Full time

Job summary

Catalent is seeking a Quality Assurance Inspector to ensure compliance in their Quality Assurance operations. This full-time position involves monitoring packaging processes, performing inspections, and supporting deviations and investigations, located at their state-of-the-art facility in Philadelphia. Applicants should possess a Bachelor’s degree or substantial experience in quality assurance within regulated environments.

Benefits

Defined career path and annual performance review

Generous PTO and paid holidays

Tuition Reimbursement

401K match

Medical, dental and vision benefits effective day one

Qualifications

• Requires a Bachelor’s Degree or a minimum of five years of Production/Quality Assurance experience.
• Experience in a regulated field preferred (pharma, food, automotive).
• Good Computer Skills, knowledge of MS Office is a plus.

Responsibilities

• Responsible for ensuring compliance with Standard Operating Procedures and cGMP.
• Verifies and inspects incoming materials for discrepancies.
• Perform inspection and release of clinical and commercial drug products.

Skills

Monitoring

Auditing

Attention to Detail

Problem Solving

Education

Bachelor’s Degree

Tools

MS Office

Inventory Management System

Job description

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Position Summary

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.

Quality Assurance Inspector

Position Summary

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.

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 Pharma Solutions in Philadelphia is hiring a Quality Assurance Inspector. The Quality Assurance Inspector reports to the Quality Supervisor. The Quality Inspector is responsible for process monitoring and auditing of packaging operations, the duties including real-time batch documentation review, monitoring of adherence to cGMP, training on cGMP where necessary, and supporting actions (if required) for resolution of deviations and investigations. The scope of work will cover packaging room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will identify opportunities to improve the ‘right-first-time’ performance of the operation and will manage those opportunities to implementation and improvement, in partnership with Production personnel.

This is a full-time role position: Monday-Friday: 7:45am-4:15pm. Hourly, Onsite

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. This may require simultaneous auditing and/or monitoring of one or more processes. This role can support both Commercial and Clinical Operations
• 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 products and components received from customer or vendor as per customer specifications protocols and/or Catalent SOPs, includes review of all inventory labels applied to the containers and paperwork generated from JDE with receipt paperwork
• 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. Inspect retain samples, as required. Maintains & provides departmental metrics. Assists in walk through audits of the Supply Chain facility, Label control room, Refrigerator/Freezer and associated areas to ensure cGMPs and SOPs are being followed
• Reviews Supply Chain Facility logbooks, Label Room logbooks, Pest Control logbooks and Sampling Room logbooks for GMP compliance and revises SOPs as needed
• Partners with other departments in resolving unplanned deviations, investigations, in troubleshooting, and in process improvements. Performs additional sampling/testing protocols on clinical trial materials as requested by the customer. Participate in customer audits when required. Complete & maintain documentation
• Performs other duties or tasks as requested or required by QA Management.
• All other duties as assigned;
  
  
  

The Candidate

• Requires a Bachelor’s Degree or a minimum of five years of Production/ Quality Assurance experience.
• Proven track record of monitoring/auditing for quality assurance and/or identifying potential efficiencies in a production environment preferred.
• Experience in a regulated field preferred – pharma, food, automotive, 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.
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds
• Occasional requirement to work in cold environment to fill orders (walk-in refrigerator/freezer)
  
  
  

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 effective day one of employment
• 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.

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 [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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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