Principal Specialist, Quality Control Chemistry Testing (Weekend Shift)

Cardinal Health•Indianapolis, IN

5d•Onsite

About The Position

The Principal Specialist, Quality Control Chemistry Testing serves as a technical leader within Quality Control chemistry, analyzing and inspecting products and processes for compliance with specifications, standards, and applicable regulations. The role performs visual assessments and analytical evaluations or tests, applies in-depth knowledge of testing methods and equipment, and follows established policies and procedures. It may establish testing methodologies, help develop policies and procedures, and provide technical guidance and training on SOPs and quality guidelines. The specialist conducts analysis of incoming materials, in-process materials, and product samples; supports method and equipment qualification activities; performs stability testing; and carries out laboratory investigations and related quality-system work. The role authors and optimizes documentation, serves as a subject matter expert, collaborates with other departments on analysis and special projects, and champions Quality, cGMP compliance, and EHS/Radiation Safety practices. The position reports to the Manager, Quality Control (Chemistry). The weekend shift is Friday through Sunday, 12:00 PM to 12:00 AM. The primary work environment includes a professional office within a radiopharmaceutical manufacturing facility, materials warehouse, and laboratory. The controlled facility is regulated by state and federal agencies, and employees receive training and routine monitoring related to radiation exposure. Noise levels are low to moderate. The listed anticipated salary range is $82,100 to $105,480 per year. The position is not bonus eligible. Benefits include medical, dental and vision coverage, paid time off, a health savings account, a 401(k) savings plan, access to wages before payday through myFlexPay, flexible spending accounts, short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.

Requirements

Bachelor’s degree or previous work experience in a similar role or related science field preferred.
At least 5 years of relevant work experience involving 21 CFR 210 and 211 in an FDA-regulated pharmaceutical or medical device industry.
Experience authoring documentation such as SOPs, change controls, CAPAs, deviations, and laboratory investigations.
Proficiency in Microsoft Word and Microsoft Excel.
Strong technical writing skills.
Ability to work the Friday–Sunday shift from 12:00 PM to 12:00 AM.
Detail-oriented, organized, able to multitask, and self-motivated.
Strong communication skills and ability to listen to and explain difficult issues.
Ability to work calmly and patiently under pressure or stressful conditions.
Professional conduct, integrity, composure, and ability to work successfully in a team environment.

Nice To Haves

Bachelor’s degree or previous work experience in a similar role or related science field is preferred.
Experience working with analytical testing, instrumentation, quality processes, or regulated laboratory documentation.

Responsibilities

Perform analysis of incoming materials, in-process materials, and product samples.
Provide technical mentoring and training to chemistry department personnel.
May lead and facilitate qualification of applicable analytical instrumentation.
Execute method verification, validation, and/or transfer protocols; analytical equipment qualification protocols; or computer system validation test scripts.
Perform stability testing according to stability protocols and prescribed cadence.
Perform laboratory investigations, change controls, deviations, and corrective/preventive actions as needed.
Author and optimize SOPs, analytical testing forms, and other documents as necessary.
Serve as a subject matter expert for aspects of analytical testing, instrumentation, and/or processes.
Perform special projects or tasks as needed based on skills, development goals, and business needs.
May collaborate with multiple departments to coordinate and facilitate analysis and special projects.
Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
Perform other job duties as assigned.
Adhere to established policies and procedures and applicable regulations and standards.
Take actions to continually improve quality and safety, report errors appropriately, and maintain required training and regulatory compliance.
Build cross-functional relationships and communicate effectively to explain complex issues and reach shared understanding.