Senior Specialist, Quality Assurance

Qualifications

• 2-4 years of experience in a cGMP, preferred
• Bachelor’s of Science preferred – Chemistry or Biology degree highly preferred or previous work experience in a similar role or related field
• Experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations is highly preferred
• Possesses and understanding of cGMP and compliance requirements for CFR 210/211 and/or 212 and the EU is a plus
• Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills
• Experience using Veeva Vault is a plus

Responsibilities

• Reviews cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, and production and process controls
• Reports metrics related to products and processes
• Establishes and maintains quality assurance procedures
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices
• Actively partners with site management and personnel in troubleshooting quality deficiencies and implementing corrective measures to eliminate quality problems
• Covers document and record processing in eQMS system
• Maintains GMP record retention
• Affirms quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements and requirements
• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Qualifications

The Senior Specialist, Quality Assurance reviews cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, and production and process controls. Reports metrics related to products and processes. Establishes and maintains quality assurance procedures. Champion Quality, cGMP compliance, and EHS/Radiation Safety practices. Actively partners with site management and personnel in troubleshooting quality deficiencies and implementing corrective measures to eliminate quality problems. Coordinates document and record processing in eQMS system. Maintains GMP record retention. Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements and requirements.

Anticipated Salary Range

$68,500.00-$88,020.00

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage. Paid time off plan. Health savings account (HSA). 401k savings plan. Access to wages before pay day with myFlexPay. Flexible spending accounts (FSAs). Short- and long-term disability coverage. Work-Life resources. Paid parental leave. Healthy lifestyle programs.