Position Summary

Under general direction, the QA Specialist I is a quality professional who manages quality activities at BSM to meet cGMP and regulatory requirements at BSM. The QA Specialist I is responsible for maintaining and improving the Quality Culture at BSM.

Duties and Responsibilities

• Assist with maintenance of quality systems to support clinical and commercial and development activities at BSM
• Review and approve material lot release activities
• Review and approve material specifications
• Review and approve stability protocols and stability data packets
• Review and approve Excursions
• Work within guidelines established by company policy and delegated authority
• Maintain control and confidentiality of documents and information
• Provide quality guidance to development of analytical methods and other documents related to Method Transfer and Qualification as needed
• Review protocols, test methods and other documentation associated to Method Transfer as needed
• Other duties as assigned

Regulatory Responsibilities

• Comprehensive understanding of cGMP, 21 CFR 210/211 and other regulatory agency requirements which apply to quality operations and compliance
• Conduct all work in compliance with FDA, 21 CFR 210 and 211, and other regulatory agency requirements.
• Comprehensive understanding of FDA, EU, and other regulatory agency requirements

Supervisory Responsibilities

• N/A

Experience

• At least one (1) years’ related experience in a cGMP environment
• One (1) or more years of QA experience preferred

Education

• Bachelor’s degree in scientific discipline, preferred

Knowledge, Skills & Abilities

• Attention to detail
• Organization and prioritization
• Ability to shift to changing priorities
• Performance under pressure in a fast-paced environment to meet deadlines
• Successfully manage timelines to meet corporate goals
• Oral and written communication
• Ability to work in a productive cross-functional manner
• Skilled in Microsoft Office and general computer proficiency

Physical Requirements

• Use of standard office equipment with or without reasonable accommodation