Specialist I - Quality Assurance Systems, Deviations/CAPAs

Catalent Pharma Solutions; Alabama; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

PTO 152 hours + 8 holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, Wisconsin is seeking a Specialist I - Quality Assurance Systems, Deviations/CAPAs to manage Investigation and CAPA activities on-site. The role emphasizes leading deviation handling, supporting OOS investigations, and enhancing the Quality System in a fast-growing biotech environment.

Ideal candidates hold a STEM degree with substantial related experience and have strong cross-functional collaboration abilities, with a focus on regulatory compliance and

Qualifications

• Doctorate Degree in STEM with 0+ related experience or equivalent educational background.
• Master’s Degree in STEM with 4+ years of related experience.
• Bachelor’s Degree in STEM with 6+ years of related experience.
• Associates Degree in STEM with 10+ years of related experience.

Responsibilities

• Accountable for the Investigation and CAPA Management Systems.
• Responsible for managing complex deviations and supporting OOS investigations.
• Drives alignment and improvement initiatives across cross-functional teams.

Education

Doctorate Degree in STEM

Master’s Degree in STEM

Bachelor’s Degree in STEM

Associates Degree in STEM

Tools

CAPA software

Job description

Specialist I - Quality Assurance Systems, Deviations/CAPAs

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

Catalent Pharma Solutions in Madison, WI is hiring a Specialist I - Quality Assurance Systems, Deviations/CAPAs.

The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

The Role:

• Accountable for the Investigation and CAPA Management Systems.
• Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems.
• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes.
• Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.
• Provides technical assistance and training for personnel.
• Files and maintains controlled documents.
• Other duties as assigned

The Candidate:

• Doctorate Degree in STEM discipline with minimum of 0 years related experience.
  OR
• Master’s Degree in STEM discipline with minimum of 4 years related experience.
  OR
• Bachelor’s Degree in STEM discipline with minimum of 6 years related experience.
  OR
• Associates Degree in STEM discipline with minimum of 10 years related experience.
  

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement- Let us help you finish your degree or start a new degree!

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.

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 [e-mail]. 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.

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