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Quality Assurance Inspector

Company: Catalent Pharma Solutions
Location: Philadelphia
Posted on: April 11, 2021

Job Description:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here Job Title Position Summary The Quality Inspector is responsible for performing inspection and release of all components, clinical trial and commercial labels, drug products, distribution materials and paperwork as well as materials slated for destruction and associated paperwork, while ensuring SOPs and cGMP are being followed. The Quality Inspector role is critical to our patients. Ensuring product quality, and identifying opportunities to improve the processes, with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!-- The Role (daily responsibilities)

  • 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 the simultaneous auditing and/or monitoring of one or more processes.
  • 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, 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
  • Assists in walk through audits of the Logistics facility, Label control room, Refrigerator/Freezer and associated areas to ensure cGMPs and SOPs are being followed.
  • Reviews Logistics 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.
  • Participates in customer audits when required.
  • Performs other duties or tasks as requested or required by QA Management. The Candidate (requirements)
    • Minimum of a High School Diploma with 2+ years in Logistics/Quality
    • Bachelor's Degree Preferred. Will consider Bachelor's Degree with 0-2+ years' experience.
    • Good Communication Skills, both written and verbal.
    • Strong interpersonal skills and is comfortable working in a team environment, as well as independently.
    • Good Computer Skills. Knowledge of MS Office and Inventory Management system are a plus.--
    • Good knowledge of the application of FDA cGMP's .
    • Exercise sound judgment and is analytical in thought.
    • Is comfortable working in a dynamic environment with many conflicting priorities.
    • Ability to be on feet and move easily throughout the Logistics facility.
    • Ability to quickly learn and implement QA Auditing techniques. Catalent's standard leadership competencies that are used to interview and for Performance & Development:
      • Leads with Integrity and Respect
      • Delivers Results
      • Demonstrates Business Acumen
      • Fosters Collaboration and Teamwork
      • Champions Change
      • Engages and Inspires
      • Coaches and Develops
      • Competitive benefits and 401K plan
      • Opportunities for growth
      • 19 days of PTO 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. C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 DisabilityAccommodations@catalent.com . 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. Full time 0052952 About Us Catalent = Catalyst + Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if---
        • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
        • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!
        • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
        • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
        • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
        • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here .--

Keywords: Catalent Pharma Solutions, Philadelphia , Quality Assurance Inspector, Professions , Philadelphia, Pennsylvania

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