Principal Specialist, Quality Control Chemistry Testing (Weekend Shift)

Cardinal Health•Indianapolis, IN

1d•$82,100 - $105,480

About The Position

The Principal Specialist, Quality Control Chemistry Testing performs quality control analysis and inspection of products and processes for compliance with specifications, standards, and applicable regulations. This role serves as a technical leader within Quality Control chemistry, performing visual assessments and analytical testing, establishing test methodologies, and contributing to policies and procedures. The specialist may provide technical guidance and training on standard operating procedures (SOPs) and quality guidelines. The position works in a professional office environment, radiopharmaceutical manufacturing facility, materials warehouse, and laboratory. The facility operates under closely monitored conditions regulated by state and federal agencies. Staff receive radiation-safety training and are routinely monitored for radiation exposure. Noise levels are low to moderate. The schedule is 12:00 PM–12:00 AM, Friday through Sunday. The role reports to the Manager, Quality Control (Chemistry).

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 working with 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 and communication skills.
In-depth knowledge of work processes and tools within the area, with ability to function as a subject matter expert.
Ability to work effectively in a team, communicate difficult issues, listen actively, and build alignment.
Detail-oriented, organized, able to multitask, and self-motivated.
Ability to remain calm and patient under pressure or stress and communicate with honesty, transparency, and clarity.
Ability to meet the physical requirements of the role, including occasional lifting or moving of up to 25 pounds and frequent standing, walking, handling objects, reaching, balancing, and stooping, kneeling, crouching, or crawling.

Nice To Haves

Bachelor’s degree or previous work experience in a similar role or related science field.
Experience with analytical testing, instrumentation, or process expertise in a chemistry department.

Responsibilities

Analyze incoming materials, in-process samples, and product samples.
Serve as a technical mentor and provide training to personnel in the chemistry department.
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 and preventative 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 based on skill set, development goals, and business needs.
May collaborate with the Supervisor and/or Manager and other 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 regulatory requirements.
Identify opportunities to improve quality, safety, and work processes; report errors in a timely and appropriate manner.
Maintain required training appropriate to position requirements.