Specialist I, Quality Assurance

Socket.dev; Kansas; On-site; USD 55,000 - 75,000; Full time

Job summary

Catalent is seeking a Specialist I, Quality Assurance at our Kansas City site to audit lab data for GMP compliance and review critical documentation, ensuring adherence to FDA, European, and other guidelines. The role includes processing quality documents, performing data verification and audits, leading facility audits, and reviewing Certificates of Analysis and Stability Protocols, following GMP and GDP practices.

Shift: M-F 8am-5pm; Location: Kansas City, MO; 100% onsite.

Qualifications

• Bachelor’s degree in a science-related field with 4+ years of related work experience, or Master’s degree with no experience required.
• Clear communicator in written and verbal form; seeks answers from standards and regulations.
• Demonstrates Catalent Leadership Competencies at the Individual level.
• Responds to problems and identifies solutions; develops methods to address constraints.
• Collaborates effectively with others; communicates necessary information.
• Ensures compliance with regulations, policies, and standards.

Responsibilities

• Process documents submitted to Quality, including scanning, printing, and filing
• Perform laboratory data verification and data audits
• Lead laboratory facility audits
• Review and approve Certificates of Analysis, Analytical Result Forms, Stability Reports, and Stability Protocols
• Follow Good Manufacturing Practices and Good Documentation Practices to ensure compliance with FDA, European, and other applicable guidelines
• Perform all other duties as assigned

Skills

Clear communication

Analytical thinking

Collaboration

Ethical conduct

Quality mindset

Education

Bachelor’s degree in science

Master’s degree in science

Job description

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 Specialist I, Quality Assurance to join our team. In this role, you will focus on auditing laboratory data to ensure compliance with procedures and regulations in the pharmaceutical industry. You will review critical documentation and support quality processes to maintain high standards. This position plays a key role in ensuring adherence to Good Manufacturing Practices and regulatory guidelines.

Shift: M-F 8am-5pm

Location: Kansas City, MO

100% Onsite

The Role

• Process documents submitted to Quality, including scanning, printing, and filing
• Perform laboratory data verification and data audits
• Lead laboratory facility audits
• Review and approve Certificates of Analysis, Analytical Result Forms, Stability Reports, and Stability Protocols
• Follow Good Manufacturing Practices and Good Documentation Practices to ensure compliance with FDA, European, and other applicable guidelines
• Perform all other duties as assigned

The Candidate

Minimum Requirements

• Bachelor’s degree in a science-related field and 4+ years of related work experience, or Master’s degree in a science-related field with no experience required
• Clear communicator in written and verbal form; seeks answers from standards and regulations and escalates when needed
• Demonstrates Catalent Leadership Competencies at the Individual level: Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and Develops
• Responds to problems and identifies solutions; develops methods to address constraints and waits for approval before implementation
• Collaborates effectively with others; handles conflict constructively and communicates necessary information
• Builds trust by acting ethically and inclusively; ensures compliance with regulations, policies, and standards; raises questions or concerns when needed

Preferred Skills & Background

• Veterinary or Human Pharmaceutical Quality Assurance or Quality Control experience strongly preferred

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback
• Diverse and inclusive culture
• Opportunities for career growth within an organization dedicated to improving lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective on day one
• 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.

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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.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.