Principal Specialist, Quality Control Chemistry Testing (2nd Shift)

Cardinal Health; Indiana (PA); On-site; USD 81,000 - 116,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

HSA

Paid time off

MyFlexPay access

Job summary

Cardinal Health is seeking a Principal Specialist, Quality Control (Chemistry) to lead analytical testing and ensure product compliance within a radiopharmaceutical manufacturing facility. You will mentor staff, develop test methods, and maintain adherence to cGMP, regulatory standards, and safety guidelines.

The role reports to the Manager, Quality Control (Chemistry) and requires deep knowledge of analytical instrumentation, method validation, and CAPA processes.

Qualifications

• Bachelor’s degree or equivalent experience in science field.
• 5+ years in FDA-regulated pharma/medical device (21 CFR 210, 211)
• Experience in SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations
• Proficient in MS Word and Excel with strong technical writing skills

Responsibilities

• Performs analysis of incoming materials, in-process, and product samples.
• Leads training and mentoring in chemistry department.
• Leads qualification of analytical instrumentation.
• Executes method verification, validation, transfer protocols, instrument qualification, or computer system validation scripts.
• Performs stability testing per protocols.
• Conducts laboratory investigations, change controls, deviations, and CAPAs as needed.
• Authors and optimizes SOPs and testing documents.
• Acts as SME for analytical testing, instrumentation, or processes.
• Collaborates with multiple departments on projects.
• Champions quality, cGMP compliance, and EHS safety.

Skills

5+ years experience

FDA regulations 21 CFR 210/211

SOPs & CAPAs

MS Word & Excel

Education

Bachelor’s degree in science

Tools

Analytical instrumentation

Computer System Validation

Job description

Principal Specialist, Quality Control (Chemistry)

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. What a Principal Specialist, Quality Control (Chemistry) contributes to Cardinal Health Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. Reports to Manager, 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. Adheres to established policies and procedures. Establishes test methodology and may contribute to the development of policies and procedures. May provide technical guidance and training to others on SOPs and quality guidelines.

What is expected of you and others at this level

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. Gain awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between QC and your role. Exhibit professional conduct, respect for others, and understands how to be successful in a team environment. Is detail oriented, organized, had 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 but not limited to maintaining required trainings as appropriate to position requirements. Has 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. Actively builds relationships across functions/businesses that bring value to the company, encouraging the participation and perspectives of all team member, regardless of background.

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.

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 he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate. This position is second shift and has hours of M-F, 3:30 p.m. - Midnight

Compensation

• Anticipated salary range: $80,900.00-$115,500.00
• Bonus eligible: No

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well‑being.

• 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

Equal Opportunity & Diversity

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 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.

About the Company

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.