QA Compliance Specialist II or III
- 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, deviations, CAPA’s, change controls and other relevant GMP records for compliance.
- Participate and act as QA lead on project teams and provide necessary support to meet required project deadlines.
- Support Quality Systems programs and processes which may include but is not limited to master batch record/production batch record review, internal and external audits, inspections and release for materials and product, process product returns and complaints.
- Provide and obtain relevant cGMP and other Quality-related training.
- Provide timely project/monthly progress reports.
- Perform routine tracking and trending analysis.
- Cross train in departmental duties to assist in meeting the resource needs of the department as assigned.
- Position may require travel domestically.
Minimum Educational Requirements for Competency:
- Minimum BA/BS degree or minimum 3 years related experience in FDA-regulated industry in vaccine, biologics or pharmaceutical industry with at least 1 year quality experience including:
- Possessing strong customer service, analytical and problem solving abilities
- Familiarity with Trackwise or other electronic Quality Management Systems
- Proficiency in Microsoft Office with ability to input data into other software programs
- Good communication and organization skills
- Must have excellent attention to detail
- ASQ Certification (or equivalent Quality Certification) preferred
This position will be based in Alachua, FL.
To apply submit your resume to email@example.com with the position in the subject line.