Specialist I - Quality Assurance Operations, Data Review

Work Schedule: Monday–Friday, 8:00 AM–5:00 PM, 100% on-site

About the role

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. Employees are helping to improve future patient outcomes by working on products designed to treat COVID-19, cancer, autoimmune and fibrotic disorders, blood disorders, HIV, diabetes, heart and lung diseases, and Alzheimer’s.

The Quality Assurance department ensures compliance with FDA and other regulatory agency requirements as well as internal quality systems. Responsibilities include systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. The Quality Assurance Operations group oversees manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

Responsibilities

• Maintain and enhance the effectiveness of the Quality System by 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 acceptance range.
• Ensure analysts follow all applicable SOPs and CGMP regulations; work with analysts for document corrections and provide guidance.
• Interface with clients and manage internal communication to sustain and enhance client quality relationships.
• Review and approve quality control–related deviation investigation records.
• Maintain sufficient understanding of quality systems and operations to provide consultation and guidance for Quality Control personnel regarding execution of the Quality Management Systems.
• Notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Perform other duties as assigned.

Requirements

• Doctorate Degree in a STEM discipline with a minimum of 0 years related experience, or
• Master’s Degree in a STEM discipline with a minimum of 4 years related experience, or
• Bachelor’s Degree in a STEM discipline with a minimum of 6 years related experience, or
• Associate’s Degree in a STEM discipline with a minimum of 10 years related experience.
• Proficiency with Excel, Word, and other office systems.
• Prior work experience with quality management software such as TrackWise® or ComplianceWire®.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture and positive working environment focused on continual process improvement and innovation.
• Potential for career growth on an expanding team within an organization dedicated to preserving and improving lives.
• 152 hours of PTO plus 8 paid holidays.
• Generous 401K match.
• Medical, dental, and vision benefits effective on day one of employment.
• Tuition reimbursement.