Senior QC Data Review Specialist

Cardinal Health, Inc.; Legendary Hills (IN); On-site; USD 81,000 - 104,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account

401k savings plan

myFlexPay access

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Control (Data Review) to lead technical aspects of QC chemistry, mentor staff, and ensure regulatory compliance.

You will guide method verification, instrument qualification, and investigations while improving quality systems across the site. You will act as SME for analytical testing and processes, drive SOPs, CAPAs, and change controls, and collaborate with multiple departments to deliver compliant results in a high-stakes

Qualifications

• Bachelor's degree or previous work experience in a similar role or related science field.
• 4-8 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
• Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.

Responsibilities

• Performs analysis of incoming materials, in-process, and product samples.
• Serves as a technical mentor and training to personnel working in the chemistry department.
• May lead and facilitate the qualification of applicable analytical instrumentation.
• Executes method verification, validation, and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts.
• Performs stability testing in alignment with stability protocols at the prescribed cadence.
• Performs laboratory investigations, change controls, deviations, and corrective/preventative actions as needed.
• Authors and optimizes SOPs, analytical testing forms, and other documents as necessary.
• Serves as a subject matter expert (SME) for aspects of analytical testing, instrumentation, and/or processes.
• Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
• May assist the Supervisor and/or Manager by serving as a collaborator with multiple different departments to coordinate and facilitate analysis and special projects.
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
• Performs other job duties as assigned.

Skills

Technical leadership

Regulatory knowledge

Technical writing

SOP development

Education

Bachelor's degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Control (Data Review) to lead technical aspects of QC chemistry, mentor staff, and ensure regulatory compliance.

You will guide method verification, instrument qualification, and investigations while improving quality systems across the site. You will act as SME for analytical testing and processes, drive SOPs, CAPAs, and change controls, and collaborate with multiple departments to deliver compliant results in a high-stakes