Quality Assurance Specialist II

ROLE SUMMARY

The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to resolve quality issues, lead investigations, and ensure timely product release. QA Specialist II partners with cross-functional teams to implement improvements and maintain compliance with regulatory standards..

ROLE RESPONSIBILITIES

• Evaluate and approve batch documentation and exercise judgment in determining product disposition based on compliance standards.
• Provide quality 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 and resolve non-conformances in manufacturing operations; recommend corrective and preventive actions to management.

• Perform timely reviews and make informed decisions on batch acceptability and product disposition.
• Operate effectively in a team environment and collaborate across departments with minimal guidance, applying professional judgment under short timelines while maintaining quality standards.
• Collect, analyze, and report departmental data to support quality metrics and continuous improvement initiatives.
• Contribute to training and mentoring Quality Assurance colleagues to strengthen team capability.
• Has the ability to understand and demonstrate aseptic techniques and behavior required in aseptic processing areas
• Apply knowledge of manufacturing operations and quality procedures to ensure compliance with regulatory requirements and proactively influence process improvements.

• 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 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.
• Must be willing to work weekends and holidays as needed to support business initiatives

• Other tasks assigned by management requiring application of professional judgment and quality expertise.

BASIC QUALIFICATIONS

• Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 3 years experience in the Pharmaceutical or related industry
• Experience in Batch Record Review/Audit/Disposition
• The ideal candidate will possess a combination of relevant education, 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
• Works in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Must have effective written and oral communication skills.
• Collects, researches, analyzes, and presents data information skillfully.
• 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.
• It is required to sit, stand and occasionally lift items (up to ~25 pounds), performing the duties of this position.
• 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. Note that these activities may not be time bound to core hours or presence at the site.

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