Sharp Services is seeking a Quality Assurance Specialist to ensure compliance with cGMP standards and oversee the accuracy of documentation related to quality assurance processes. The ideal candidate should possess a relevant degree and 3-5 years of experience in a cGMP environment, demonstrating strong attention to detail and organizational skills
Job Summary
The Quality Assurance Specialist ensures cGMP compliance and adherence to SOPs through the review and approval of compliance documentation.
Responsibilities include reviewing and approving batch records, components, labels, and analytical reports, as well as preparing Annual Product Review reports.
The role involves participating in and leading audits, assisting with audit findings and CAPA generation, and participating in investigations of deviations and non-conformances.
Matching Summary
Match Score: 85
Sharp Services is seeking a Quality Assurance Specialist to ensure compliance with cGMP standards and oversee the accuracy of documentation related to quality assurance processes. The ideal candidate should possess a relevant degree and 3-5 years of experience in a cGMP environment, demonstrating strong attention to detail and organizational skills.
Skills & Requirements
Must-have
cGMP compliance
SOP adherence
batch record review
analytical report review
internal audits
Nice-to-have
FDA and EU regulations
training employees
clean, orderly and safe work environment
Key Requirements
3-5 years relevant work experience
Bachelors’ Degree, Associates Degree, or equivalent
Ability to interpret and implement cGMPs, FDA & DEA Regulations and CFRs
Strong working knowledge of Microsoft Office Products