Lead Quality Assurance Specialist (Quality Systems - External Customer Audits)

Catalent Pharma Solutions, Inc. Baltimore , MD 21203

Posted 2 months ago

The Lead Quality Assurance Specialist (Quality Systems - External Customer Audits) is responsible for supporting Quality Systems, including hosting client/regulatory inspections, conducting for cause and internal audits as assigned, coordinating audit logistic planning/prep, inspection readiness training, drafting audit reports and responses, conducting inspection readiness/compliance training, 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. Exercise judgment within defined Quality Assurance and Manufacturing procedures to determine appropriate action for resolution of manufacturing issues.

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent?

The Role:

  • Host scheduled client audits and ad-hoc regulatory inspections, which includes drafting audit responses, tracking CAPA closure and outgoing communication.

  • Coordinates on-site client audits, preparation of audit materials, and ensure timely response and resolution to client observations, to include but not limited to; management of outgoing communication, audit document prep, and meeting logistics

  • 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.

  • Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team; Facilitate risk assessments for site using applicable tools (FMEA, HAACP, etc)

  • Manage, and lead internal audit program which includes creating annual schedule, creating audit agenda, drafting audit reports, tracking CAPA closure and drafting outgoing communication

  • Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization

  • Other duties as assigned

The Candidate:

  • Minimum of a B.S. in a Life Sciences discipline

  • +6 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry and +4 years' experience in Quality / Compliance function

  • ASQ (American Society of Quality) or RAPS (Regulatory Affairs Professionals Society) highly desirable

  • Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems

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.


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Lead Quality Assurance Specialist (Quality Systems - External Customer Audits)

Catalent Pharma Solutions, Inc.