QA Inspector (Production) 2nd shift role
Summary
A global leader in Clinical Supply, Catalent partners with sponsors to accelerate and scale their trials with innovative, flexible and reliable supply solutions. Catalent provides comprehensive and integrated services for sponsors and studies of all sizes with 25+ years experience spanning 5,000 studies in more than 80 countries. We offer full-service packaging, cold chain distribution and specialized capabilities across the globe to solve clinical supply challenges.
Our offerings include:
•Clinical supply management/forecasting
•Direct comparator/reference product sourcing
•Clinical manufacturing, packaging, and labeling
•Specialty handling (high potent/cytotoxic and controlled substances)
•Cold chain capabilities (ambient to cryogenic)
•Clinical storage, distribution, and returns management
The Quality Inspector (Production 2nd shift) is responsible for creating/maintaining the Quality Management System for the Clinical Services facility at Philadelphia. The Quality Inspector (Production 2nd shift) responsibilities also include Documentation Control, Investigation and CAPA Management, Training, Internal/External Audits, Customer Correspondence, Validation, and includes Quality Assurance of the Operation such as process monitoring and control, quality auditing including batch record review and final release.
Requirements:
The role of the Quality Inspector (Production 2nd shift) is critical to the end user which are our patients. It directly affects patients risk and safety if inspections are not done properly according to cGMPs, DEA and OSHA rules and regulations. Quality, safety, and on-time delivery is a must to be successful in this role!
The Role
•Responsible for ensuring that Standard Operating Procedures are consistently followed and that cGMPs are observed, in the course of packaging operations. This may require the simultaneous auditing and/or monitoring of one or more operations.
•Verifies and reconciles materials to and from Clinical Production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies.
•Inspects and releases all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents all activities accordingly in the associated logbook.
•Supports and assists Mechanics on the execution of Operational Verifications (OVs) and Set-Up Records (SURs) both prior to the start and during the process (if necessary) for any jobs using validated or non-validated equipment respectively.
•Performs and documents hourly QA Inspections on assigned clinical packaging rooms as per both the QA Protocol and SOPs requirements as well as ensuring that the Production Protocol and GMP standards are being followed.
•Reviews the batch record and any associated paperwork for any documentation errors made during the clinical packing operation and again when the job is completed prior to submitting the batch record to document control.
•Reviews EMS system printouts for out of specification temperatures, humidity and pressures.
•Ensures that all Inventory Management System printed labels are correct against the information provided in the associated protocol.
The Candidate
•High school degree required with a minimum of 3 years of Production/QA experience or Bachelors degree preferred (BA, BS)
•Proven track record of monitoring/auditing for Quality and of identifying potential efficiencies in a Production environment.
•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 (JD Edwards 9.1 preferred)
•Ability to quickly learn and implement QA Auditing techniques.
•Ability to work 2nd shift, weekend/overtime if needed
Catalents 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
Position Benefits
•Lots of Growth/Development opportunities
•19 Days of PTO (Paid Time Off) per year
•Tuition Reimbursement Program
About Catalent
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. More products. Better treatments. Reliably supplied.
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Visit www.catalent.com/careers to explore career opportunities.
Catalent 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
