Principal Specialist, Quality Control Chemistry Testing (Weekend Shift)

This role operates on a weekend shift from 12:00 PM - 12:00 AM, Friday - Sunday.

About the role

Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. The Principal Specialist, Quality Control (Chemistry) performs visual assessment and analytical evaluation or testing of products/processes, demonstrates knowledge of testing methods, product usage, and applicable regulations and standards, and adheres to established policies and procedures. This role establishes test methodology and may contribute to the development of policies and procedures, and may provide technical guidance and training to others on SOPs and quality guidelines.

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.

Requirements

• Serves as a technical leader within Quality Control chemistry.
• 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.
• Gains awareness of other departments at site and seeks to understand their functions and points of interaction between QC and your role.
• Exhibits 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 maintaining required trainings as appropriate to position requirements.
• Has the ability to act calmly and patiently when working under pressure and/or 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 members, regardless of background.

Qualifications

• Bachelor’s degree or previous work experience in a similar role or related science field preferred.
• 5+ 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.

Physical/Mental Requirements

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.

Work Environment

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 will be routinely monitored for exposure to radiation.
• Noise levels are considered low to moderate.

Pay

Anticipated salary range: $80,900 - $115,500.

Benefits

• 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.