Job Description

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!

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