Operations Compliance Specialist

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

Job summary

An established industry player is seeking an Operations Compliance Specialist to join their Kansas City facility. This full-time, onsite role is crucial for ensuring regulatory compliance and patient safety in the pharmaceutical sector. You'll leverage your technical writing skills and experience in GxP environments to facilitate investigations, propose corrective actions, and author standard operating procedures. Join a diverse and innovative team dedicated to delivering life-saving products and enjoy career growth opportunities, generous PTO, and a supportive work culture. Make a meaningful impact in the healthcare industry!

Benefits

401K match

Tuition reimbursement

Generous PTO

Wellness programs

Employee Resource Groups

Community engagement initiatives

Qualifications

• 2+ years in pharmaceutical packaging and distribution preferred.
• Experience in technical writing in a GxP setting.

Responsibilities

• Facilitate Rapid Response Team fact gathering and write investigation reports.
• Utilize lean and Six Sigma tools to solve quality issues.

Skills

Technical Writing

Problem-Solving

Analytical Skills

Lean Six Sigma

Education

High School Diploma or GED

Bachelor's Degree

Tools

SOPs

GxP Standards

Job description

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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 experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of over a hundred new products annually. Powered by thousands of scientists and technicians across more than 40 global sites, Catalent supplies billions of doses of treatments each year.

Location and Facility Details:

Catalent’s Kansas City facility specializes in Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services. It offers integrated services for oral solid dosage forms, from formulation to analytical testing and manufacturing. The site is a Center-of-Excellence for biologics analytical services, with a team experienced in biologics projects.

Role Overview:

This is a full-time, onsite role at our Kansas City, MO location. The Operations Compliance Specialist provides technical and regulatory expertise to investigation and deviation management processes, ensuring patient safety, regulatory compliance, and inspection readiness.

Responsibilities:

1. Participate in and facilitate Rapid Response Team fact gathering.
2. Write investigation reports that clearly communicate what happened, why, and when.
3. Propose CAPAs to prevent future events.
4. Utilize lean and Six Sigma tools to address root causes of quality issues.
5. Facilitate cross-functional problem-solving events.
6. Author SOPs and work instructions.
7. Review investigation documentation for OOS, OOT, atypical results, and deviations from regulations or policies.
8. Perform other duties as assigned.

Candidate Qualifications:

• High School Diploma or GED required; Bachelor’s Degree preferred or equivalent experience.
• Minimum two years’ knowledge of pharmaceutical packaging, distribution, SOPs, and GxPs preferred.
• At least one year of technical writing experience in a GxP environment.
• Lean, Six Sigma, SPC experience preferred.
• Proactive problem-solving and analytical skills.
• Ability to sit, stand, walk regularly, and occasionally lift up to 40 pounds.

Why Join Catalent:

• Defined career path with performance reviews.
• Diverse, inclusive culture.
• Innovative work environment.
• Career growth opportunities.
• Generous PTO and holidays.
• Employee Resource Groups focusing on D&I.
• Community engagement and green initiatives.
• 401K match, benefits from day one, tuition reimbursement, wellness programs, and discounts.

Join us in making a difference by bringing life-saving products to patients worldwide. Visit Catalent Careers for more opportunities.