Quality Assurance Specialist I

About the role

The QA Specialist I provides quality oversight and compliance support for operations including equipment and material preparation, aseptic compounding, filling, inspection, and packaging activities. This role applies knowledge of cGMP and regulatory standards to review documentation, monitor processes, and support investigations. The QA Specialist I collaborates with cross-functional teams to maintain compliance and contribute to continuous improvement initiatives.

Responsibilities

• Review and evaluate manufacturing and testing documentation to ensure compliance with SOPs and cGMP requirements, applying professional judgment where needed.
• Provide quality oversight and guidance during shop floor activities, inspection readiness, and in-process checks, including deviation and laboratory investigations, change management, SOP revisions, and batch documentation review.
• Identify and escalate quality issues and contribute to root cause analysis and corrective actions to maintain compliance standards.
• Collaborate with cross-functional teams to support process improvements and ensure adherence to regulatory requirements.
• Collect, analyze, and report departmental data to identify trends and support continuous improvement initiatives.
• Assist in training and mentoring QA colleagues, sharing best practices to strengthen team capability.
• Demonstrate proficiency in aseptic techniques and behaviors required in aseptic processing areas.
• Apply knowledge of manufacturing operations and quality procedures to proactively influence compliance outcomes.
• Communicate issues identified during batch production or record reviews promptly to management, demonstrating accountability and ownership of quality standards.
• Review and edit SOPs, logbooks, and batch records for accuracy and regulatory alignment.
• Participate in internal GMP audits and support customer and regulatory audits.
• Assist in review and editing of SOPs and Master Batch Records.
• Perform ERP transactions, as applicable.
• Work weekends and holidays as needed to support business initiatives.
• Perform other tasks assigned by management requiring application of professional judgment and quality expertise.

Requirements

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 1 year of experience in the Pharmaceutical or related industry.
• 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.
• Ability to work in a team environment within own team and interdepartmental teams.
• Ability to work under short timelines while maintaining quality work.
• Effective written and oral communication skills.
• Skill in collecting, researching, analyzing, and presenting data.
• Certified Quality Auditor (CQA) Certification preferred.

Physical Qualifications

• Position requires vision acuity testing and onsite attendance; this position cannot be performed remotely.
• Must be able to complete aseptic gowning qualification and work in a Grade A/B classified area.
• Must be able to sit, stand, and occasionally lift items up to ~25 pounds.
• Must have the ability to multi-task across multiple capabilities and functions, handle competing priorities, and respond to frequent email and phone communications.