What are the responsibilities and job description for the Specialist I, Quality Assurance position at Catalent?
About Site
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
Position Summary
We have an opportunity for a Quality Specialist I to join our team supporting clinical trial projects. In this role, you will help ensure compliance with regulatory requirements, good manufacturing practices and standard operating procedures. You will maintain accurate documentation and support quality assurance processes throughout the product lifecycle. This position offers the chance to contribute to continuous improvement initiatives and develop your expertise in a dynamic environment.
Shift: Monday-Friday; 12:00pm - 8:00pm
Location: Kansas City, MO
100% Onsite
The Role
Minimum Requirements
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.
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
Position Summary
We have an opportunity for a Quality Specialist I to join our team supporting clinical trial projects. In this role, you will help ensure compliance with regulatory requirements, good manufacturing practices and standard operating procedures. You will maintain accurate documentation and support quality assurance processes throughout the product lifecycle. This position offers the chance to contribute to continuous improvement initiatives and develop your expertise in a dynamic environment.
Shift: Monday-Friday; 12:00pm - 8:00pm
Location: Kansas City, MO
100% Onsite
The Role
- Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
- Create Certificate of Analysis with supervision. Adhere to GMP standards with guidance and create limited errors
- Support clinical trial projects ensuring compliance with regulatory requirements, good manufacturing practices and standard operating procedures.
- Implement and maintain quality assurance processes throughout the product lifecycle.
- Ensure all documentation is accurate, up-to-date and properly maintained in accordance with regulatory requirements.
- All Other Duties as Assigned.
Minimum Requirements
- Bachelor’s degree in a scientific discipline or equivalent knowledge and experience.
- High school degree with 2 years of Quality Assurance experience in a GMP manufacturing environment.
- 20/30 corrected vision exam with colorblindness testing.
- Nurse assessment and pulmonary physical.
- Respirator fit test.
- DEA background check relating to controlled substance products.
- Ability to work in refrigerator (35°F – 46°F / 2°C – 8°C) and/or freezer (-4°F / -20°C) environments.
- Ability to work near machinery and packaging equipment.
- Ability to identify aberrant data and potential quality or compliance concerns and escalate to management.
- Ability to work effectively under pressure to meet deadlines.
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive paid time off plus 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental and vision benefits effective day one of employment.
- Tuition reimbursement.
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.