Senior Specialist, Quality Control Chemist II

About the role

Quality Control contributes to Cardinal Health's quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Responsibilities

• Reports to Supervisor, Quality Control (Chemistry)
• Ensures timely and thorough inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples.
• Performs investigations, deviations, change controls and CAPAs.
• Executes method verification, validation and/or transfer protocols.
• Performs stability testing in alignment with stability protocol(s) at the prescribed cadence.
• Authors standard operating procedures, analytical method worksheets, forms and other documents as necessary and applicable.
• Demonstrates detail-oriented attention in all facets of responsibilities.
• Performs visual assessment and analytical evaluation or test of products or processes.
• Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.
• Adheres to established policies and procedures.
• Establishes test methodology.
• May train others on SOPs, PROTOCOLs, instruments and quality guidelines.
• May execute analytical equipment qualification protocols or computer system validation test scripts.
• Aligns work priorities with immediate supervisor/management.
• Gains awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between Quality Control and your role.
• Exhibits Cardinal Health's high ethical standards and code of conduct.
• Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
• Performs other job duties as assigned.

Qualifications

• Bachelor’s degree or previous work experience in a similar role or related field, chemistry, or biology preferred.
• 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
• Has general knowledge of GDP documentation practices and requirements.
• Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Works well with others and understands how to be successful in a team environment.
• Absorbs detail, is organized, able to multitask, a self-starter, and self-motivated.
• Is proficient in Microsoft Word and Microsoft Excel and possesses strong technical writing skills.
• Collaborates with people and works on a team.
• Communicates effectively.

Benefits

• Medical, dental and vision coverage
• Paid time off (Untracked)
• 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