Quality Specialist

Position: Quality Specialist I
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 all work complies with regulatory requirements, good manufacturing practices and standard operating procedures. You will be responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This includes ensuring documentation is accurate, current, and properly maintained in line with regulations.

Shift: M-F 10am-6pm

Location:

Kansas City, MO 100% Onsite

The Role Demonstrate proven competence and ability to flex to the next level for growth opportunities

Participate in continuous improvement initiatives to enhance processes, systems, and procedures related to quality management

Inspect components and materials, perform cleaning procedures for sampling, and complete all associated paperwork

Create Certificates of Analysis with supervision and adhere to GMP standards with guidance

Review quality control data for completeness and acceptability, approve release packets, and perform material release with supervision

File batch record documentation, review documents, and perform red actions with supervision

Support floor quality assurance activities including in-process audits, cleaning, line clearance, and inspections under supervision

Perform label inspections and releases, and line clearance activities with supervision

Review and approve quality actions and effectiveness checks, lead investigations for deviations and complaints, and host CAPA review meetings

Track and trend metrics, perform effective rapid response, and maintain DME training

Host change control review board meetings, review and approve change controls, engineering studies, and periodic reviews with supervision

The Candidate

Minimum Requirements High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment

Ability to follow instructions and guidance from others

Use existing procedures to solve routine problems

Proactive in addressing work issues at the individual level

Ability to follow written, oral, diagram, or schedule instructions

Mathematical and scientific reasoning ability

Ability to identify aberrant data and escalate quality or compliance concerns

Ability to work effectively under pressure to meet deadlines

Proficient in using computers and related technology for common tasks
20/30 corrected vision exam with colorblindness testing

Nurse assessment and pulmonary physical

Respirator fit testDEA background check for controlled substance products

Ability to work in refrigerated (35F – 46F / 2C – 8C) and freezer (-4F /
-20C) environments

Ability to work near machinery and packaging equipment

Preferred Skills & Background Bachelor’s degree in a scientific discipline or equivalent knowledge and experience

Why You Should Join Catalent Defined career path with annual performance reviews and feedback

Diverse and inclusive culture

Potential 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 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…