QA Specialist 2

Role Summary

QA Specialist 2 on-site role focused on real-time on-the-floor quality oversight of manufacturing activities at a cGMP site, supporting the CMC clinical manufacturing program. Emphasis on aseptic technique, GMP principles, batch record review, and deviations. Collaboration with Manufacturing, Quality Control, Validation, Supply Chain, and Facility teams.

Responsibilities

• Provide quality on-the-floor support of manufacturing processes, reviewing batch record documentation, and providing real-time support of manufacturing, issues, changeovers, etc.
• Participate in quality oversight of manufacturing through real-time observations of activities; provide guidance on GMP principles and aseptic technique during routine operations.
• Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation; establish and follow written procedures for documentation of equipment operation, process instructions, and process data.
• Perform routine walkthroughs of the manufacturing suites, partnering with manufacturing on suite maintenance, quality best-practice implementation, and troubleshooting.
• Review Environmental Monitoring results associated with GMP operations.
• Support quality decisions that may impact operations, ensuring appropriate escalation.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Review and approve facility alarms, facility work order requests, inventory requests, batch record requests, and return-to-service documentation.
• Support, review, and approve Deviations and Change Controls.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Make quality decisions that may impact operations, escalating to management when needed.
• Partner with manufacturing and support teams to initiate and triage new deviation events, and review minor and major manufacturing deviations.
• Oversee execution of remediation/CAPA activities to continue production or move a process to the next milestone.
• Manage multiple assignments and/or projects in a fast-paced environment.
• Collaborate and lead effectively in a dynamic, cross-functional matrix environment.
• Author and review SOPs and policies to ensure compliance with regulations/cGMP operations.
• Participate in quality-focused teams across the organization.
• Support internal audits.
• Collaborate with Manufacturing and Quality Operations to ensure appropriate and rapid disposition of clinical products.
• Demonstrate knowledge of standard manufacturing compliance, quality disposition, and quality system review; use knowledge to improve operational efficiency.
• Work with others to recognize opportunities for improvement and drive change through Quality systems.
• All other duties as assigned.

Qualifications

• Bachelor‚Äôs degree in applied science.
• 2+ years‚Äô relevant experience in Quality Assurance, ideally within cGMP aseptic manufacturing operations.
• Preferred experience in cell or gene therapy.
• Weekend work may be required based on business needs.
• Strong organizational, analytical, and time management skills.
• Ability to work well in a team environment with a positive attitude and willingness to assist other areas.
• Excellent verbal and written communication skills with strong attention to detail.
• Ability to handle multiple tasks simultaneously with strong attention to detail.
• Ability to perform frequent physical tasks with strength and mobility; flexible scheduling required.
• Equivalency may substitute for education/experience/training.

Education

• Bachelor‚Äôs degree in applied science.