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Senior Specialist, Quality Assurance
2 months ago
About the Role
We are seeking a highly skilled Quality Assurance Specialist, Senior to join our team at Hispanic Technology Executive Council. As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services, and contributing to the development and implementation of quality policies, procedures, and processes.
Key Responsibilities
- Perform quality review and approval/release decisions at a regulated manufacturing facility.
- Handle CGMP documentation review related to product release, facilities, equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
- Establish and report metrics related to products and processes as deemed necessary by the Regional Quality Manager.
- Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
- Handle and ensure quality of documentation (control, retention, and archival) to support CGMP activities.
- Engage and collaborate with operations department to drive quality system and CGMP requirements.
- Perform product release activities per CGMP requirements.
- Monitor CAPA in investigations and close when completed or escalate (if necessary).
- Perform aseptic review of the site with operations and document results.
- Report quality system issues to the RQM and others as necessary.
Requirements
- Bachelor's degree in a related field, or equivalent work experience.
- 2-4 years of experience, preferred.
- Proficiency with MS Excel and MS Word.
- Effective written and verbal English communication skills.
- Strong attention to detail.
- Ability to lift between 30-45 lbs.
- Pharmaceutical or medical device experience a plus.
- ISO experience a plus.
Work Environment
The primary work environment consists of a manufacturing pharmacy that 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.
What We Offer
- Competitive salary range: $74,500-$106,400.
- Bonus eligible: No.
- Benefits: 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.
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
