Quality Assurance Biopharma

Quality Assurance a

Description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? A leading clinical and commercial biologics CDMO is focused on creating innovative solutions to meet client needs and improve patient outcomes.

Your Role

The Quality Assurance Specialist (Lot Disposition) is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

Key Responsibilities

• Perform assigned tasks and work to achieve company goals and department objectives by following company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Collaborate with Management to establish and meet targets and timelines.
• Independently manage competing priorities with limited instruction.
• Serve as a Quality representative on cross-functional and multi-site teams.
• Identify and recommend solutions to potential procedure, process, and system gaps.
• Provide assistance to customers in support of departmental functions.
• Participate in the design and implementation of department and cross-functional initiatives.
• Apply basic theory and technical principles to address moderately complex problems.
• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Sign documents for activities as authorized and described by company policies, procedures, and job descriptions.
• Perform tasks as requested by Management to support Quality oversight activities.
• Review Manufacturing Batch Production Records.
• Review Manufacturing forms and paperwork associated with Batch Production Records.
• Assist in the release of API batches and lots.
• Compile and perform QA review of Batch History Records.
• Review testing documentation from Microbiology and Chemistry groups.
• Review and approve controlled documents relating to processes, equipment, facilities, and utilities used in manufacturing.
• Represent Quality Assurance on multi-disciplinary project teams.
• Write and assist with excursion reports.
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
• Provide Quality oversight to internal and external customers.
• Collaborate with departments to ensure all review activities are executed efficiently per governing SOPs.
• Generate departmental performance metrics for management review.
• Perform other duties as assigned.

Minimum Qualifications

• Bachelor’s degree (preferably in Life Science).
• Minimum 2–4 years of experience in the biopharmaceutical industry.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation.
• Ability to independently evaluate situations and propose potential solutions.