Specialist I, Quality Assurance

Regulatory Toolkit; Kansas City (MO); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Medical, dental and vision benefits on

Tuition reimbursement

Paid time off + 8 holidays

Job summary

Catalent is seeking a Quality Assurance Specialist I for our Kansas City, MO site to support clinical trial projects and ensure compliance with GMP and regulatory requirements. You will maintain accurate documentation and contribute to quality assurance processes across the product lifecycle in a 12:00pm–8:00pm shift, onsite.

Responsibilities include participating in continuous improvements, preparing Certificates of Analysis, and ensuring timely, compliant records and procedures.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

GMP

Documentation

Regulatory compliance

Continuous improvement

Education

Bachelor’s degree in a scientific discipline

Job description

SpecialistI, Quality Assurance

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

• 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.

Preferred Skills & Background

• Ability to identify aberrant data and potential quality or compliance concerns and escalte to management.
• Ability to work effectively under pressure to meet deadlines.

Why You Should Join Catalent

• 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.

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.

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.

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Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

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