Quality Assurance Specialist

THIS POSITION WILL BE ONSITE IN ONE OF THE FOLLOWING LOCATIONS: San Francisco Bay Area / Dallas TX / Miami FL / New Jersey

*Relocation support will be considered for this role

Overview of Role:

The Specialist Quality Assurance will report to Quality Assurance leadership and support GMP compliance related to drug substance and drug product manufacturing processes. This role will contribute to quality assurance activities ensuring compliance with applicable regulations and industry standards. The Specialist will assist in inspection readiness efforts support batch review and release processes and work crossfunctionally to maintain and improve quality systems.

Role and Responsibilities:

• Support the development implementation and maintenance of GMP quality systems including policies procedures and risk assessments in alignment with global health authority regulations (FDA EMA ICH etc..
• Assist in ensuring GMP compliance at Contract Manufacturing Organizations (CMOs) by providing sponsor oversight and supporting clinical and commercial manufacturing activities.
• Participate in inspection readiness activities including documentation preparation and coordination for internal audits and regulatory inspections.
• Assist with investigations root cause analysis risk assessments and corrective and preventive actions (CAPAs) to ensure timely resolution of qualityrelated issues.
• Support internal QA batch review and release processes to ensure compliance with applicable regulations.
• Review and help maintain controlled documents including Standard Operating Procedures (SOPs) to align with regulatory requirements and industry best practices.
• Collaborate with crossfunctional teams to achieve quality and compliance objectives.
• Assist in tracking and maintaining quality metrics and performance indicators.
• Perform other duties as assigned to support Quality Assurance initiatives.

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in chemistry biochemistry life sciences biotechnology or a related field.
• Minimum of 2 years of relevant experience in the pharmaceutical or biotechnology industry with a focus on GMP manufacturing. Preferred 4 years of experience.
• Experience with biologics essential; familiarity with analytical laboratory testing is a plus.
• Experience working with eQMS systems (e.g. MasterControl TrackWise) to execute quality processes.
• Understanding of GMP requirements for clinical and commercial biologics manufacturing.
• Experience supporting audits and regulatory inspections is a plus.
• Strong organizational skills with the ability to handle multiple projects in a fastpaced environment.
• Excellent attention to detail problemsolving abilities and a strong sense of work ethic.
• Effective communication and collaboration skills with the ability to work crossfunctionally.
• Fluency in Mandarin is a plus.

The pay range for this role is $95000$110000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

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