Catalent Pharma Solutions

Specialist, Quality Assurance

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 manufacture. 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.

Catalent Pharma Solutions in Kansas City, MO is hiring a QA Specialist in Batch Record QA. Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required at the QA Associate level. This individual follows established protocols and work plans, and may be assisted by laboratory technicians / assistants.

This is a full-time hourly position Monday-Friday, 1st shift with core hours 9am-3pm with flexibility to start earlier/later.

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 the Quality support functions associated with the packaging of products for clinical and commercial batches. Performs batch record review, product release, and disposition

• Reviews production logbooks for GMP (Good Manufacturing Practices) compliance as each operation is completed and revises SOPs (Standard Operating Procedures) as needed

• Ensures that products are manufactured, packaged, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOPs

• Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines. Ensures gathering of data, investigations and deviations are timely and compliant

• Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label control)

• Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines

• Respond and interact with internal and external clients in a professional and timely manner. Receives and provides instruction, guidance and direction from/to others

• Uses existing procedures to solve routine and non-routine problems. Utilize all elements of the quality system to identify, classify and control the status of finished products produced

• All other duties as assigned

The Candidate:

• A high school diploma/GED is required with a minimum of 10 years of QA experience in a GMP manufacturing environment. We will also accept a Bachelor’s degree in a scientific discipline with 3+ years of experience, or a Master’s degree in a scientific discipline with no experience.

• Six Sigma or ASQ certification preferred. Experience with Trackwise, JD Edwards, EDMS (Electronic Document Management System) and SharePoint preferred

• Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form. Mathematical and scientific reasoning ability

• Ability to identify irregular data and potential quality/compliance concerns escalating to management

• Excellent written and verbal communications skills with internal and external customers, peers and managers. Ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment. Must be well-organized with ability to multitask

• 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

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• 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

• Competitive salary

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• 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 (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 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .