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Cardinal Health

Distributes medicines and medical supplies

QC Microbiology Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeIndianapolis, IN, USA$106.7k - $152.4kIn-person

About the Job

Requirements

  • A bachelor's degree in Microbiology, Biology, or a related science field is required; an advanced degree is preferred.
  • At least 7–10 years of relevant work experience working with 21 CFR 210 and 211 in an FDA-regulated pharmaceutical or medical device industry.
  • Experience with equipment qualification, software validation, test method validation, environmental monitoring, and/or process validation.
  • Understanding of the Validation and Technology Transfer process, with experience writing procedures and reports and executing laboratory tests.
  • Proficiency in Microsoft Word and Microsoft Excel, and strong technical writing skills.
  • Ability to work collaboratively in a team environment.
  • Detail-oriented, organized, able to multitask, self-starting, and self-motivated.

Responsibilities

  • Oversee microbiology laboratory systems to ensure data are generated in accordance with applicable regulations and company policies and procedures.
  • Oversee and maintain the Environmental Monitoring Program as required.
  • Recommend approval or rejection of starting materials, intermediate materials, and finished products.
  • Develop and apply practices that enable the laboratory to meet or exceed customer and regulatory standards cost-effectively.
  • Collaborate with the validation team and maintenance regarding laboratory equipment in the microbiology labs to determine conformance with applicable procedures and good practices.
  • Inspect, investigate, and take samples to monitor factors that may affect product quality.
  • Ensure all necessary testing is carried out and associated records are evaluated.
  • Assist with and/or conduct laboratory investigations of discrepancies, resolve problems, and work with management to ensure corrective or preventive actions are implemented in a timely manner.
  • Keep abreast of developments in microbiology by reading current technical literature and attending technical meetings.
  • Recommend improvements to management to improve laboratory performance.
  • Ensure proper laboratory hygiene and monitor storage conditions for materials and products used in the labs.
  • Foster timely and effective communication and ensure quality issues are escalated to appropriate management levels.
  • Advise on purchases of laboratory supplies that directly affect quality.
  • Assist with training and development of laboratory personnel.
  • Carry out responsibilities in accordance with the company’s Safety, Quality, Ethics, and Environmental Management policies and procedures, Vision, and Strategy, exercising good judgment, common sense, and diplomacy.
  • Produce and review personal development plans for team members, identifying and providing appropriate training.
  • Ensure Safety, Quality, or Site actions are completed effectively and on time, and ensure an escalation process is in place for quality issues.
  • Perform other job duties as assigned.

Desired Qualifications

  • An advanced degree.

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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