Associate, Quality AssurancePosition 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 Associate, Quality Assurance (QA) is responsible for quality oversight of manufacturing “floor” activities and the associated in-process GMP (Good Manufacturing Practices) records. In addition to day-to-day responsibilities, the QA Associate will identify and participate in opportunities to improve processes.This is a full-time hourly position: Monday-Friday: 1st shift with hours between 6am-2:30pm.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 oversight of the Quality support functions associated with the manufacturing of products
Performs batch record review, cleaning log review, and complete monthly and daily facility audits
Ensures with a clear understanding that products are manufactured according to applicable cGMPs, FDA (Food and Drug Administration) guidelines, MHRA (Medicines and Healthcare products Regulatory Agency) guidelines, regulations GXPs and internal SOPs (Standard Operating Procedures) as necessary to accomplish daily tasks
Identify deviations during manufacturing and provide direction as to the appropriate course of action
Review and approve batch documentation to adherence to SOPs and cGMPs
Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines
Assist with manufacturing floor activities (equipment/room approval, facility compliance)
Other duties as assigned
The Candidate:
High school diploma required with 3+ years Manufacturing/Quality Assurance experience in a GMP manufacturing environment. Will also accept Bachelor’s degree in a life science or business-related field with no experience.
Must have experience with batch record review, floor QA, reviewing of equipment logs and documents, room approvals/line clearances, preferably in a pharmaceutical or regulated industry.
Must have ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
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 50 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 (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .