Quality Assurance Specialist

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 50,000 - 90,000; Full time

Job summary

Join a leading global contract development and manufacturing organization as a Quality Assurance Specialist. In this full-time role, you will ensure that products meet the highest quality standards and comply with FDA regulations. This position offers a dynamic work environment where you can leverage your expertise in quality assurance and contribute to life-saving products. With a commitment to excellence and a patient-first culture, you will be part of a team dedicated to improving lives through innovative solutions. Enjoy a comprehensive benefits package and opportunities for career growth in a supportive and inclusive workplace.

Benefits

Defined career path

Diverse, inclusive culture

Positive working environment

Generous 401K match

Medical, dental, and vision benefits

Tuition reimbursement

WellHub program

Employee Resource Groups

Community engagement initiatives

Paid holidays

Qualifications

• 10+ years of QA experience in a GMP environment or a degree with relevant experience.
• Ability to follow complex instructions and identify quality concerns.

Responsibilities

• Responsible for quality support functions for clinical and commercial batches.
• Ensure compliance with FDA guidelines and internal SOPs.

Skills

Quality Assurance

GMP Compliance

Batch Record Review

Data Analysis

Leadership

Education

High School Diploma

Bachelor's Degree in Science

Master's Degree in Science

Tools

Trackwise

JD Edwards

EDMS

SharePoint

Job description

Quality Assurance Specialist

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

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 Quality Assurance Specialist. The Specialist will perform work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. They will comply with divisional and site Environmental Health and Safety requirements.

This is a full-time, on-site salary position: Monday – Friday, 1st shift.

Catalent is committed to a Patient First culture through excellence in quality andcompliance, 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
• Assists in the execution of efficiency improvement projects with guidance
• 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
• Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
• All other duties as assigned

The Candidate:

• A high school diploma or general education diploma is required with a at least ten years of QA experience in a GMP manufacturing environment; we will also accept a Bachelor’s degree in a scientific discipline with at least three years of experience, or a Master’s degree in a scientific discipline with no experience
• Six Sigma or ASQ certification is 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 preferred
• Ability to identify irregular data and potential quality/compliance concerns escalating to management
• Ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment is preferred
• 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 include 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
• 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.

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 [e-mail]. 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 [e-mail] for us to investigate with local authorities.

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