Senior Specialist, Quality Control Chemist II

Cardinal Health; Indianapolis (IN); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Job summary

Cardinal Health in Indianapolis, IN, is seeking a Quality Control professional (Chemistry) to perform inspections and analyses of materials, substances, and products to ensure compliance with regulatory standards.

You will execute method verification/validation, participate in deviations and CAPAs, and prepare SOPs and test forms. Strong detail orientation, teamwork, and communication are essential; experience with GDP documentation and Microsoft Word/Excel is expected.

Qualifications

• Bachelor’s degree in chemistry or biology or equivalent experience.
• 2+ years in FDA regulated industry (21 CFR 210, 211) preferred.
• Experience authoring SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Strong attention to detail, teamwork, and communication.

Responsibilities

• Inspect incoming materials, Drug Substance, in-process and drug product samples.
• Perform investigations, deviations, change controls and CAPAs.
• Execute method verification, validation and/or transfer protocols.
• Perform stability testing per protocol and cadence.
• Train others on SOPs, PROTOCOLs, instruments and quality guidelines.

Skills

Teamwork

Detail oriented

Multitasking

Self-motivation

Communication skills

Technical writing

Education

Bachelor’s degree in Chemistry or Biology

Tools

Microsoft Word

Microsoft Excel

Job description

What Quality Control contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.

Responsibilities

Reports to Supervisor, Quality Control (Chemistry) Ensures timely and thorough inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples. Performs investigations, deviations, change controls and CAPAs. Execute method verification, validation and/or transfer protocols. Perform stability testing in alignment with stability protocol(s) at the prescribed cadence. Authors standard operating procedures, analytical method worksheets, forms and other documents as necessary and applicable. Demonstrates detail-oriented attention in all facets of responsibilities. Performs visual assessment 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. May train others on SOPs, PROTOCOLs, instruments and quality guidelines. May execute analytical equipment qualification protocols or computer system validation test scripts. Aligns work priorities with immediate supervisor/management. Gain awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between Quality Control and your role. Exhibits Cardinal Health's high ethical standards and code of conduct. Performs special projects or tasks as necessary based on skill set and/or development goals and business needs. Performs other job duties as assigned. Required to have visual acuity and color perception Near-vision performance should be the equivalent of 20/20 with no impairment of color vision or correctable to 20/20 vision with the use of corrective lenses.

What is expected of you and others at this level

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. 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. 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 field chemistry, or biology preferred. 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. Has general knowledge of GDP documentation practices and requirements 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 self-starter, and self-motivated. 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.

Anticipated salary range: $68,500.00-$88,020.00

Bonus eligible: No

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

Application window anticipated to close: 11/8/2026

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.