Position Summary:

The QC Sample Management Supervisor will provide oversight and maintenance of Catalent’s Quality Control sample management program. In this foundational role, at our newest manufacturing facility, the successful candidate will create study set up and testing coordination both internally and externally.

This position will be Monday-Friday 8am-5pm with occasional weekends required.

The role:

• Manage Catalent’s Quality Control sample, shipment, aliquoting, and critical reagents programs
• Document writing (laboratory investigations, out of specifications, deviations, CAPAs), inventory control tracking, statistical analysis, and trending
• Recommends, leads projects associated to and drives to completion all continuous quality improvements in the QC laboratory
• Conducts training on applicable SOPs, regulatory requirements and quality initiatives
• Ensure compliance to procedures; perform root cause analyses and trend analyses; develop and implementing corrective actions; improve procedural efficiencies
• Manage and monitor on-time closure of assigned laboratory investigations, deviations, and investigations
• Participate in employee development programs and objective goal setting sessions
• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
• Produce results in a fast-paced environment in order to meet client deadlines, and under minimal supervision
• Ability to learn quickly with a desire for continual development and improvement
• Work with QC Lab Management to maintain QC laboratories in an audit ready status

The candidate:

• Bachelor in a science or analytical discipline
• 8 or more years of experience in Quality Control with some or all that time holding an analytical, sample management, or related role, preferred.
• 4 years of direct people leadership, preferred
• Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance (US and EU) specifically related to Stability.
• Experience in writing SOPs, investigations and resolving deviations
• Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve problems related to Quality Control Sample Management, as well as routine quality tasks
• Ability to succeed in a team-oriented environment under very dynamic conditions
• LIMS experience preferred

Why you should join Catalent:

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross functional exposure to other areas of within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 19 days of paid time off annually + 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

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