Senior Quality Assurance Specialist

Role Responsibilities

• Lead and approve complex document reviews to ensure manufacturing and testing processes comply with approved batch/testing records, SOPs, and cGMP standards.
• Provide strategic QA oversight and guidance for manufacturing and testing activities, including shop floor support, inspection readiness walk-throughs, line clearance, in-process checks, deviation and laboratory investigations, change management, SOP revisions, and batch documentation review.
• Independently identify, resolve, and influence corrective actions for non-conformances in manufacturing operations; drive systemic improvements to prevent recurrence.
• Perform timely reviews and exercise judgment in determining batch acceptability and product disposition for high-impact decisions.
• Operate effectively in a team environment and collaborate cross-functionally to lead quality initiatives, applying advanced judgment under short timelines while maintaining compliance and quality standards.
• Collect, analyze, and interpret departmental data to identify trends and recommend improvements that enhance quality systems.
• Lead training, mentoring and process improvement efforts for Quality Assurance colleagues to build organizational capability.
• Demonstrate advanced proficiency in aseptic techniques and behaviors required in aseptic processing areas.
• Apply deep knowledge of manufacturing operations and quality procedures to influence compliance strategies and process optimization.
• Communicate issues identified during batch production or record reviews promptly to management, demonstrating accountability and ownership of quality outcomes.
• Review and approve SOPs, Forms, Logbooks, and Master Batch Records for accuracy and regulatory alignment.
• Participate in internal GMP audits and represent QA as a subject matter expert during customer and regulatory audits.
• Support review and approval of SOPs and Master Batch Records to maintain compliance standards.
• Perform ERP transactions as applicable to ensure accurate documentation and system integrity.
• Lead identification, management, and execution of projects associated with the Quality Unit to drive continuous improvement and compliance excellence.

Basic Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 5 years experience in the Pharmaceutical or related industry.
• Experience in Batch Record Review/Audit/Disposition.
• Aseptic training and manufacturing/quality experience.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Demonstrated decision-making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on overall quality, site priorities, results and achievements.
• Demonstrated capability in project management.
• Works in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Effective written and oral communication skills.
• Certified Quality Auditor (CQA) Certification preferred.

Physical Qualifications

• Position requires vision acuity testing and onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
• The candidate must be able to complete aseptic gowning qualification and work in a Grade A/B classified area.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls.