Title: Quality Manager
Location: Albany, OH (Can Provide Relocation)
A leading pharmaceutical company just launched a brand new 503b facility and is rapidly expanding their site. They are looking for a Quality Manager to lead QA and QC activities for this new site.
Responsibilities:
- Review and approve Quality documentation (batch records, SOPs, deviations, change controls, OOS investigations, etc.)
- Create annual product reviews, review/approve label changes
- Provide assistance and leadership in regulatory inspections
- Oversee incoming materials, sample reserve, and sterility assurance programs
- Support vendor management and assist with vendor qualification activities
- Host FDA audits and Regulatory inspections
Qualifications:
- Bachelor's degree with 7+ years of relevant experience
- Ability to lead QA/QC activities and work in a fast-paced startup environment
- Must have experience with batch disposition and sterility
- Must have experience hosting FDA audits and regulatory inspections
If this sounds of interest, please don't hesitate to apply!
