Principal Specialist I, Quality Assurance

Principal Specialist I, Quality Assurance 

Summary

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Principal Specialist, QA is responsible for leading and supporting Quality Systems, including investigation/deviation management, CAPA tracking, and change control. This position will facilitate the compiling, trending and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. 

This is a full-time on-site position, Monday – Friday 8am-5pm.

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

• Supports administration for CAPA, Investigation, and Deviation systems. Includes, facilitating the closure of items with the applicable departments to ensure completion and timely resolution.
• Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on a routine basis.
• Performs CAPA effectiveness evaluation based on quantitative and qualitative measurements.
• Administer the Change Control process for the site and conduct effectiveness verification for changes implemented. 
• Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization.
• Continuously monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Provide compliance support and expertise for QA department.
• Participate in compliance remediation plans and implementation.
• Author deviations/investigations/CAPA/change controls as needed.
• Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
• Trains, as needed, organization on various quality and compliance subject matter. May include training content development and delivery for qualifying personnel.
• Supports on-site client audits, preparation of audit materials, and ensure timely response and resolution to client observations. 
• Conducts and/or supports internal audits.
• Works cross-functionally with departments to review and improve upon performance and compliance.
• Participate in site quality and process improvement initiatives. Represent QA on site project teams.
• Actively participates in training activities, managing their individual training plan.
• Other duties as assigned.

The Candidate

• Masters’ degree in a Scientific, Engineering or Biotech field with 10 – 15 years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance function.

OR

• Bachelor’s degree in a Scientific, Engineering or Biotech field with 20+ years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance function.
• Prior people leadership experience preferred 
• Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820 
• Expert knowledge of biological regulations (21 CFR Part 600s) or EU GPs, a plus 
• Ability to train, coach, and mentor junior cGMP supporting personnel 
• Proficient with data analytics and concepts
• Excellent writing skills 
• Ability to quickly learn and navigate systems 
• Able to work in a team setting and independently under minimum supervision 
• Ability to work in fast paced environment supporting the quality assurance/quality control departments of a CMO for clinical and commercial manufacturing of biologic bulk drug substance.
• Creative individual with excellent trouble shooting skills 
• Requires the ability to produce results in a fast-paced environment to meet client deadlines 

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of paid time off annually + 8 paid holidays 
• Competitive salary with yearly bonus potential 
• Community engagement and green initiatives 
• Generous 401K match and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• 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.

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.

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