Quality Assurance Compliance Specialist/Auditor (II or III)
Responsibilities and Authority:
- Monitor and continuously improve the Quality System by evaluating supporting documentation to ensure compliance to cGMP, industry standards and other applicable regulations.
- Write and review standard operating procedures, test methods, work instructions, forms, material specification sheets, master batch records, and production batch records, CAPA’s, change controls and Quality Agreements
- Master Batch Record /Production Batch Record Review
- Develop all necessary documents to meet project timelines
- Assist in internal and external audits
- Perform inspection and release for product.
- Provide cGMP and other Quality related training
- Document and check returns and complaints
- Project/monthly progress reports
- Perform tracking and trending analysis
Minimum Educational and Experience Requirements for Competency:
- Minimum BS degree required
- Good communication and organization skills
- Must have excellent attention to detail
- Proficient in Microsoft Word and Excel and able to input data into other Microsoft programs
- Minimum 5 years experience in biologics or pharmaceutical Quality Assurance preferred.
This position will be based in Alachua, FL.
To apply submit your resume to firstname.lastname@example.org with the position in the subject line.