Total Quality Analyst assists with the administration of the organization's total quality programs and processes. Conducts reviews and inspections of internal and vendor processes and activities to monitor compliance. Being a Total Quality Analyst collects data and prepares documents and charts to report status of programs. May be certified in methodologies such as Six Sigma, Lean, or Kaizen. Additionally, Total Quality Analyst typically requires a bachelor's degree in area of specialty. Typically reports to a manager or head of a unit/department. The Total Quality Analyst occasionally directed in several aspects of the work. Gains exposure to some of the complex tasks within the job function. To be a Total Quality Analyst 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