Quality Assurance Analyst, Sr. - Healthcare analyzes quality assurance and compliance data and prepares reports. Designs solutions to quality management issues. Being a Quality Assurance Analyst, Sr. - Healthcare may assist in the implementation of quality improvement processes. May assist less experienced analysts. Additionally, Quality Assurance Analyst, Sr. - Healthcare requires a bachelor's degree. Typically reports to a supervisor or manager. The Quality Assurance Analyst, Sr. - Healthcare occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Quality Assurance Analyst, Sr. - Healthcare typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Responsibilities Include the Following:
Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
Ensure that deviations from established procedures are documented per procedures.
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Alert management of quality, compliance, supply and safety risks.
Complete required assigned training to permit execution of required tasks.
Preferred Qualifications:
Bachelor’s Degree & 4 year of Quality/Manufacturing experience
cGMP Experience
Excellent written and verbal communication skills
Basic Qualifications
-High school/GED 4 years [Job Code Discipline and/OR Sub-Discipline] wOR k experience OR ?-Associate 2 years [Job Code Discipline and/OR Sub-Discipline] wOR k experience OR ?-Bachelor 6 months [Job Code Discipline and/OR Sub-Discipline] wOR k experience?-Master  ?
Top 3 Must Have Skill Sets:
4 years of experience required in Quality Assurance - Biotech preferred but not necessary.
Batch Record Review
Good Manufacturing Practices
Day to Day Responsibilities:
Review executed batch records
Perform quality oversight of manufacturing
Help with comments, good documentation practices
Work within team environment of quality professionals
Job Type: Contract
Pay: $28.00 - $34.00 per hour
Expected hours: 40 per week
Experience level:
Schedule:
Experience:
Ability to Relocate:
Work Location: In person