Quality Assurance Specialist, Biologics

Position Summary:

Catalent Pharma Solutions in Kansas City, MO is hiring a Quality Assurance Specialist who is responsible to audit laboratory data for adherence to procedures and regulations related to pharmaceuticals.

This is a full-time role position: Monday – Friday, days.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Follow GXP (e.g. GMP, GDP, etc) as necessary to accomplish daily tasks
• Laboratory facility, method validation and method transfer audits
• Review and approval of analytical methods, specifications, and protocols
• All other duties as assigned;
• Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines
• Review, approval and issuance of Certificates of Analysis (CofA), and Analytical Result Forms (ARF)
• Performs laboratory data audit and data verification
• Audit of Stability and Technical Reports
• Meets deadlines according to agreed timeframes and communicates adjustments as needed
• Ensures that products tested according to applicable FDA guidelines, regulations GXPs and internal SOPs

The Candidate

• Mathematical and scientific reasoning ability
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• Bachelors’ degree in a scientific discipline or equivalent experience required with 1+ years of Scientific or Quality Assurance/Quality Control Experience preferred
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
• Experience in regulated industry preferred, laboratory analysis experience preferred
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form

Why you should join Catalent:

• Positive working environment focusing on continually improving processes to remain innovative
• Competitive salary with quarterly bonus potential
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
• Community engagement and green initiatives
• Medical, dental and vision benefits effective day one of employment
• Diverse, inclusive culture
• Several Employee Resource Groups focusing on D&I
• Employee Stock Purchase Program
• Tuition Reimbursement
• Dynamic, fast-paced work environment
• Defined career path and annual performance review and feedback process
• GymPass program to promote overall physical wellness
• Generous 401K match and Paid Time Off accrual
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 19 days of PTO + 8 paid holidays

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.