Specialist - Quality Assurance Operations, Data Review

Position: Specialist I - Quality Assurance Operations, Data Review
Specialist I, Quality Assurance, Data Review

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 an Specialist I, Quality Assurance, Data Review. 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 for accuracy and compliance, and material disposition.

Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

The Role:

• Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of quality control operations.
• Review analytical and microbiology data and documentation including raw data, test methods, protocols, and reports for accuracy, completeness, and compliance in a timely manner.
• Review and report unusual or out-of-specification testing results.
• Review supporting documentation including laboratory records and associated documents to ensure traceability to raw data and verify all reagents, standards and equipment used are within the acceptance range.
• Ensure analysts follow all applicable SOPs and CGMP regulations and work with analysts for document corrections and provide guidance accordingly.
• Responsible for interfacing with clients and managing internal communication to sustain and enhance the Client quality relationships.
• Accountable for review and approval of quality control related deviation investigation records.
• Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Quality Control personnel regarding execution of the Quality Management Systems.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• 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.
• Ability to use Excel, Word, and other office systems.
• Prior work experience with quality management software such as Track Wise® or Compliance Wire®.

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…