Job Summary
The quality assurance specialist (QAS) performs all quality review and approval/release decisions at an FDA-regulated drug manufacturing facility. The facility manufactures three sterile liquid injection drugs, FDG, NaF and Vizamyl, that are used for Positron Emission Tomography (PET) scans.
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.
Monitors CAPA in investigations and closes when completed or escalates (if necessary).
Performs aseptic review of the site with operations and documents results.
Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification
Schedule: Site production hours areMonday through Friday from 1am-12pm. Rotating schedule (1am-9am and 4am -12pm). Occasional weekends may be required.
Location: Onsite in Columbus, OH
Qualifications
2-4 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred
Proficiency with MS Excel and MS Word
Interpersonal skills
Attention to detail
Prior experience working nightshift, preferred
Prior experience maintaining a filing system, preferred
Project management, preferred
Prior experience in a cGMP environment, preferred
What is expected of you and others at this level
Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes action to resolve
Applies judgment within defined parameters
Receives general guidance and may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy
Anticipated salary range:$66,500 - $95,000
Bonus eligible:No
Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
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
Healthy lifestyle programs
Application window anticipated to close: 09/14/2024 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
