Quality Assurance Specialist

Kindeva Drug Delivery•Maryland Heights, MO

3d•Onsite

About The Position

The Quality Assurance Specialist provides advanced quality oversight and uses professional judgment in product disposition, investigations, and change control. The role applies specialized knowledge to resolve quality issues, lead investigations, and support timely product release. It works with cross-functional teams to implement improvements and maintain compliance with regulatory standards. The position is onsite and requires vision acuity testing, onsite attendance, aseptic gowning qualification, and the ability to work in a Grade A/B classified area. The role requires sitting, standing, and occasionally lifting items up to approximately 25 pounds. It also involves multitasking across functions and managing competing priorities, communications, meetings, and conference calls, which may extend beyond core hours or time spent at the site.

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 investigations and corrective and preventive actions, with emphasis on quality, site priorities, results, and achievements.
Ability to work in a team environment and with interdepartmental teams.
Ability to work under short timelines while maintaining quality.
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, stand, and occasionally lift items up to approximately 25 pounds.
Ability to multitask across multiple capabilities and functions and handle competing priorities and requirements.
Willingness to work weekends and holidays as needed.

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 walkthroughs, line clearance, in-process checks, investigations, change management, SOP revisions, and batch documentation review.
Identify and resolve manufacturing non-conformances independently and recommend corrective and preventive actions to management.
Review records promptly and make informed decisions about batch acceptability and product disposition.
Collaborate across departments, exercise professional judgment under short timelines, and maintain quality standards.
Collect, analyze, and report departmental data to support quality metrics and continuous improvement.
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.
Promptly communicate issues identified during batch production or record reviews to management and take 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.
Perform ERP transactions as applicable 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.