Senior Specialist, Quality Control Chemist II

What a Senior Specialist, Quality Control (Chemistry) contributes to Cardinal Health

Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards.

• Performs visual assessment and analytical evaluation or testing of products/processes.
• Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.
• Adheres to established policies and procedures.
• Establishes test methodology and may contribute to the development of policies and procedures.
• May provide technical guidance and training to others on SOPs and quality guidelines.

• Exhibits Cardinal Health's high ethical standards and code of conduct.
• Approaches work situations with a positive and energizing style.
• Possesses in-depth knowledge of work processes and tools within own area and can function as a Subject Matter Expert (SME) for processes, tools, and equipment.
• Gain awareness of other departments k to understand the functions of those departments and the points of interaction between QC and your role.
• Exhibit professional conduct, respect for others, and understands how to be successful in a team environment.
• Is detail oriented, organized, has the ability to multi-task, and is self-motivated. Is aware of internal/external business issues and adapts work priorities in own area.
• Demonstrates strong communication skills. Effectively listens to and explains difficult issues to reach shared understanding and build alignment.
• Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
• Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
• Has the ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.
• Actively builds relationships across functions/businesses that bring value to the company, encouraging the participation and perspectives of all team member, regardless of background.
• Identifies quality events and aids in any associated investigations.

• Performs analysis of incoming materials, in-process, and product samples.
• Executes method verification, validation, and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed.
• 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.
• Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
• Performs other job duties as assigned.

• Bachelor’s degree or previous work experience in a similar role or related science field.
• 2+ 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.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop,…