A leading staffing firm is seeking a Quality Assurance Compliance Specialist for a hybrid role in Louisville, KY. The ideal candidate has a Bachelor's degree in Life Sciences, with at least 2 years of GMP/GDP compliance experience. Key responsibilities include managing temperature excursion records, leading root cause analysis, and supporting audits. This position requires strong communication skills and proficiency with Smartsheet, Excel, and other quality management tools.
Qualifications
Bachelor's degree or equivalent in Life Sciences with 2 years experience in GMP/GDP compliance.
In the absence of a Life Sciences degree, 4+ years experience in GMP/GDP compliance.
Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
Fluency in English is required.
Responsibilities
Own and manage temperature excursion records.
Lead root cause analysis sessions for deviations.
Manage CAPA records and ensure implementation.
Support audits and inspections.
Maintain up to date smartsheets for product records.
Drive continuous improvement initiatives.
Skills
Laboratory skills
Quality background
Detail oriented
Multitasking
Teamwork
Strong communication
Education
Bachelor's degree in Life Sciences
Equivalent experience in GMP/GDP compliance
Tools
Smartsheet
Excel
PowerPoint
Track wise
Veeva
SAP
Job description
A leading staffing firm is seeking a Quality Assurance Compliance Specialist for a hybrid role in Louisville, KY. The ideal candidate has a Bachelor's degree in Life Sciences, with at least 2 years of GMP/GDP compliance experience. Key responsibilities include managing temperature excursion records, leading root cause analysis, and supporting audits. This position requires strong communication skills and proficiency with Smartsheet, Excel, and other quality management tools.