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Cardinal Health

Distributes medicines and medical supplies

Principal Specialist - Quality Control Chemistry Testing

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeIndianapolis, IN, USA$82.1k - $105.5kIn-person

About the Job

Requirements

  • A bachelor's degree or previous work experience in a similar role or related science field is preferred.
  • At least five years of relevant work experience with 21 CFR 210 and 211 in an FDA-regulated pharmaceutical or medical device industry.
  • Experience authoring documentation such as standard operating procedures, change controls, corrective and preventive actions, deviations, and laboratory investigations.
  • Proficiency in Microsoft Word and Microsoft Excel, along with strong technical writing skills.
  • Ability to meet the stated physical demands, including standing, walking, handling materials, and occasionally lifting or moving up to 25 pounds.
  • Ability to work in a professional office, warehouse, and laboratory environment within a radiopharmaceutical manufacturing facility, and to complete training and routine monitoring related to radiation exposure.

Responsibilities

  • Perform analysis of incoming materials, in-process samples, and product samples.
  • Provide technical mentoring and 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 preventive actions as needed.
  • Author and optimize standard operating procedures, analytical testing forms, and other documents as necessary.
  • Serve as a subject matter expert for analytical testing, instrumentation, and/or processes.
  • Perform special projects or tasks based on skill set, development goals, and business needs.
  • May assist the Supervisor and/or Manager by collaborating with multiple departments to coordinate and facilitate analysis and special projects.
  • Champion Quality, current Good Manufacturing Practice compliance, and Environmental Health and Safety/Radiation Safety practices.
  • Perform other job duties as assigned.
  • Perform visual assessment and analytical evaluation or testing of products or processes.
  • Establish test methodology and may contribute to developing policies and procedures.
  • Adhere to established policies and procedures and applicable regulations and standards.
  • Identify improvement opportunities from process observations, outcome measures, and feedback; participate in improving work processes to meet and exceed expectations.
  • Report errors in a timely and appropriate manner and maintain required training to meet regulatory requirements.

Desired Qualifications

  • A bachelor's degree or previous work experience in a similar role or related science field.

About the Company

Cardinal Health

Distributes medicines and medical supplies

Cardinal Health distributes pharmaceuticals and medical products to pharmacies, hospitals, clinics and physician offices, mainly in the United States. Its largest business buys branded, generic and specialty medicines from drugmakers and delivers them to retail chains, independent pharmacies and health systems. The company also makes and sources Cardinal Health brand medical and surgical supplies, runs nuclear pharmacies that prepare radioactive drugs for imaging, and ships home-health supplies directly to patients. It earns most of its revenue from the margin on products it distributes, plus manufacturing, logistics and services for specialty physician practices. Cardinal Health was founded in 1971 and is based in Dublin, Ohio.

Company size
10,001+
Company stage
Not listed
Total funding
$204.5M
Headquarters
Dublin, OH
Founded
1971

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