Job Description

Full job description

Production Inspector

Position Summary:

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.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacturing. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

The Production Inspector is responsible for quality oversight of all packaging and distribution “floor” activities and the associated in-process GMP (Good Manufacturing Practices) records. The scope of this role includes quality support of supply chain, production, storage, returned goods and destruction activities and may require simultaneous auditing and/or monitoring of one or more operators. In addition to day-to-day responsibilities, the Production Inspector, Quality will identify and participate in opportunities to improve processes.

This is a full-time hourly position: Monday-Friday on 1st shift with hours between 6:30am-3pm.

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 packaging operations. This may require simultaneous auditing and/or monitoring of one or more operations. Performs walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMP are being followed
• Review and approve Parts List and other inventory system reports to ensure product quality and production efficiency. Oversee any handling of unlabeled product (bright stock) that occurs outside Packaging to prevent mix ups
• Verify line clearance and cleanings, perform in-process audits, and blinding checks associated with production activities. Review logbooks, including audit trails, for GMP compliance. Complete all TrackWise (deviations, complaints, Actions, QCAs, etc.) and Compliance Wire assignments prior to due date
• Ensure materials and product with potential quality defects are placed into QA Hold immediately and physically segregated from in process and released materials to prevent the risk of mix up or further processing until the defect is resolved and disposition is provided by the client
• Perform inspection and release of shipping and distribution activities by verifying picked material, individual randomized containers, and compliance with customer specific distribution protocols. Ensure retain and retention samples of packaging components are finished products are stored in an organized, readily retrievable manner in the appropriate storage conditions
• Actively participate in Rapid Response and partner with other departments in driving their events, deviations and investigations to closure
• Conduct routine GEMBA walks and reports all observations and needed remediations to area owners. Perform regular walk-through audits of the entire supply chain and associated support areas
• Other duties as assigned

The Candidate:

• High school diploma required, Associates degree highly preferred in a life science or business-related field
• Minimum of 1 year production/QA experience is required; 3 years highly desired. Track record of monitoring/auditing for a quality organization and identifying potential efficiencies in a Production environment
• Must have sufficient skills and knowledge in the use of computers and associated computer technology. Computer technology relates to both the hardware and software used in performing common computing tasks. (Word, Excel, Outlook, PowerPoint basics)
• Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently. May require the use of a respirator.

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 + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401K match
• Company match on donations to organizations
• 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.

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 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.

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Job Tags

Hourly pay, Holiday work, Full time, Local area, Immediate start, Worldwide, Work alone, Shift work, Monday to Friday,

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