Quality Assurance Specialist

Kindeva • Maryland Heights, MO

2d • Onsite

About The Position

The Quality Assurance Specialist provides quality oversight for manufacturing and testing activities, applies professional judgment to product disposition, investigations, and change control, and supports timely product release and compliance with regulatory standards. The role resolves quality issues, supports continuous improvement, and works with cross-functional teams to maintain quality standards.

The position requires onsite attendance and the ability to complete aseptic gowning qualification and work in a Grade A/B classified area. It includes reviewing and approving batch documentation and quality records, participating in audits, and supporting manufacturing operations. The role may require work on weekends and holidays as needed.

Requirements

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or another science-related discipline, or at least 3 years of experience in the pharmaceutical or a related industry.
• Experience in batch record review, audit, or disposition.
• Knowledge of cGMPs, including USFDA, Health Canada, PIC/S, and/or EudraLex requirements.
• Demonstrated decision-making ability related to incident investigation and corrective and preventive actions, with consideration for overall quality, site priorities, results, and achievements.
• Ability to work in a team environment within own and interdepartmental teams.
• Ability to work under short timelines while maintaining quality work.
• Effective written and oral communication skills.
• Ability to collect, research, analyze, and present data and information skillfully.
• Ability to complete aseptic gowning qualification and work in a Grade A/B classified area.
• Ability to sit and stand, and occasionally lift items up to approximately 25 pounds.
• Ability to multitask across multiple capabilities and functions and manage competing priorities and requirements.
• Ability to perform site and functional responsibilities, respond to frequent email and phone communications, and attend multiple meetings and conference calls; these activities may extend beyond core hours or time spent at the site.
• Ability to attend onsite; the position cannot be performed remotely or by telecommuting.

Nice To Haves

• Certified Quality Auditor (CQA) certification.
• A combination of relevant education, aseptic training, and manufacturing or quality experience.

Responsibilities

• Evaluate and approve batch documentation and determine 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.
• Identify and resolve manufacturing non-conformances and recommend corrective and preventive actions to management.
• Review batch records promptly and make informed decisions on batch acceptability and product disposition.
• Collaborate across departments and operate effectively in a team environment, applying professional judgment under short timelines.
• Collect, analyze, and report departmental data to support quality metrics and continuous improvement initiatives.
• Contribute to training and mentoring Quality Assurance colleagues.
• Demonstrate aseptic techniques and behavior required in aseptic processing areas.
• Apply knowledge of manufacturing operations and quality procedures to ensure regulatory compliance and drive process improvements.
• Communicate issues identified during batch production or record reviews promptly to management.
• 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.
• Perform applicable ERP transactions to ensure accurate documentation and system integrity.
• Work weekends and holidays as needed to support business initiatives.
• Perform other tasks assigned by management that require professional judgment and quality expertise.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level