Senior Specialist, Quality Control Chemist II

Schedule: Second Shift - Anticipated Sunday- Thursday 3:00 pm - 12:00 am

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

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.

Responsibilities

• 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.
• 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, kneel, crouch or crawl. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
• The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility, the materials warehouse as well as the laboratory setting.
• The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

Qualifications

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

Schedule:

• 2nd Shift - Anticipated 3:00 pm - 12:00 am
• Potential to work 1st shift, to cover PTO of other analysts
• Initial training for this role will be provided on 1st shift.

What is expected of you and others at this level

• 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 at site. Seek 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