Principal Specialist, Quality Control Chemist III

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

• Reports to Supervisor, Quality Control (Chemistry).
• Quality control is responsible for the analysis and inspection of products or materials for compliance with specifications and standards.
• Demonstrates detail-oriented attention in all facets of responsibilities.
• Performs visual inspection, dimensional measurement, physical characterization 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.
• Serves as a technical mentor and trainer to others on SOPs and quality guidelines.

Responsibilities

• Insures timely and thorough analysis of incoming materials, Drug Substance, In-Process and Drug Product samples.
• Serves as a technical mentor and trainer to personnel working in the QC Chemistry section.
• May lead and facilitate the qualification of applicable analytical instrumentation.

• Performs investigations, deviations, change controls and CAPAs.
• Serves as a subject matter expert (SME) for some aspects of analytical testing and/or instrumentation and/or processes.
• Authors and optimizes standard operating procedures, analytical method worksheets, forms and other documents as necessary and applicable.
• 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 in Chemistry or a science or science-related field preferred
• 5+ 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.
• Must work well with others and understand how to be successful in a Team environment.
• Must be detail oriented, organized, able to multi­task, a self­starter, and self­motivated.
• Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
• Demonstrated success in collaborating with people and working on a team.
• Strong communications skills.

Performance Expectations

• Demonstrates a commitment to the organization’s mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.
• Works as part of a team with others and shows respect and values diversity toward others.
• 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.
• 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.

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; talk or hear; and taste or smell. 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 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