Senior Specialist, Quality Assurance
7 days ago
We are seeking a highly skilled Senior Specialist, Quality Assurance to join our team at Cardinal Health. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our products and services.
Key Responsibilities- Perform quality review and approval/release decisions at an FDA-regulated drug manufacturing facility.
- Handle CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
- Establish and report metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM).
- 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 closes when completed or escalates (if necessary).
- Perform aseptic review of the site with operations and documents results.
- Report quality system issues to the RQM and others as necessary.
- Bachelor's degree in a related field, or equivalent work experience.
- 2-4 years of experience in quality assurance or a related field.
- 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.
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.
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