Senior Specialist, Quality Assurance

3 weeks ago

Tampa, Florida, United States Cardinal Health Full time
Job Summary

Cardinal Health is seeking a highly skilled Senior Specialist, Quality Assurance to join our team in Tampa, FL. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and services, adhering to regulatory standards and specifications.

Key Responsibilities

• Handles cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.

• Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM).

• Ensures the site manufactures products to meet the requirements of 21 CFR 212 (cGMP).

• Handles and ensures quality of documentation (control, retention, and archival) to support cGMP activities.

• Engages and collaborates with operations department to drive quality system and cGMP requirements.

• Performs product release activities per cGMP requirements.

• Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.

Requirements

• Bachelor's degree in a related field (science) preferred, or equivalent work experience preferred.

• 2+ years of experience in a related science field preferred

• 1-2 years of experience in Quality Assurance and/or cGMP regulated environment highly preferred

• Pharmaceutical or medical device experience a plus.

• Effective written and verbal English communication skills.

• ISO experience a plus.

Work Environment

The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. 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 group. 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.

What We Offer

Cardinal Health offers a wide variety of benefits and programs to support health and well-being, including 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, and healthy lifestyle programs.

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