Principal Specialist, Quality Control Chemistry Testing (Weekend Shift)

Cardinal Health; Indianapolis (IN); On-site; USD 82,000 - 105,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Access to wages before pay day with my

Long-term disability

Job summary

Cardinal Health is seeking a Principal Specialist in Quality Control (Chemistry) for the weekend shift in Indianapolis. The role leads analytical testing and method validation in a radiopharmaceutical manufacturing setting, ensuring compliance with 21 CFR and company SOPs.

Strong communication and SME-level expertise are essential to guide cross-functional teams. The position requires a Bachelor’s degree or equivalent experience with 5+ years in a regulated environment and proficiency in

Qualifications

• Bachelor’s degree or related science field with 5+ years in FDA-regulated industry (Pharma/Medical Device).
• Experience authoring SOPs, Change Controls, CAPAs, Deviations, and Lab Investigations.
• Proficient in Word/Excel with strong technical writing skills.

Responsibilities

• Performs analysis of incoming materials, in-process, and product samples.
• Serves as a technical mentor and training to personnel in the chemistry department.
• Lead qualification of analytical instrumentation.
• Executes method verification/validation and transfer protocols.
• Performs stability testing per stability protocols.
• Authors and optimizes SOPs and testing forms.
• Acts as SME for analytical testing/instrumentation.
• Collaborates with multiple departments on projects.
• Champions quality, cGMP compliance, and EHS/Radiation Safety.
• Performs other duties as assigned.

Education

Bachelor’s degree or related science field

Tools

Microsoft Word

Microsoft Excel

Job description

Principal Specialist, Quality Control (Chemistry) (Weekend shift)

What hours does a Principal Specialist, Quality Control (Chemistry) (Weekend shift) at Cardinal Health expect? This shift is expected to work from 12:00 PM - 12:00 AM, Friday - Sunday. 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.

Anticipated Salary Range

Anticipated salary range: $82,100.00-$105,480.00

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

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.

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.