Quality Assurance Specialist I

Kindeva Drug Delivery • Brentwood, MO

4d • Onsite

About The Position

The QA Specialist I provides quality oversight and compliance support for operations involving equipment and material preparation, aseptic compounding, filling, inspection, and packaging. The role applies knowledge of cGMP and regulatory standards to review documentation, monitor processes, support investigations, and collaborate across teams to maintain compliance and advance continuous improvement.

The position provides guidance during shop-floor activities and in-process checks; reviews manufacturing, testing, and batch documentation; supports deviation and laboratory investigations, change management, SOP revisions, and audits; and identifies and escalates quality issues. The specialist also analyzes departmental data, contributes to root cause analysis and corrective actions, assists with training colleagues, and performs applicable ERP transactions. The role requires onsite attendance and the ability to qualify for aseptic gowning and work in a Grade A/B classified area. Weekend and holiday work may be needed to support business initiatives.

Requirements

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or another science-related discipline, or a minimum of 1 year of experience in the pharmaceutical or a related industry.
• Knowledge of cGMPs, including USFDA, Health Canada, PIC/S, and/or Eudralex requirements.
• Decision-making ability related to incident investigation and corrective and preventive actions, with emphasis on quality, site priorities, results, and achievements.
• Ability to work in a team environment within the QA team 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.
• 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 manage competing priorities and requirements.
• Ability to attend onsite; the position cannot be performed remotely or by telecommute.

Nice To Haves

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

Responsibilities

• Review and evaluate manufacturing and testing documentation for 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.
• Support 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.
• Collaborate with cross-functional teams to support process improvements and adherence to regulatory requirements.
• Collect, analyze, and report departmental data to identify trends and support continuous improvement.
• Assist in training and mentoring QA colleagues and share best practices.
• 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.
• Promptly communicate issues identified during batch production or record reviews to management.
• Review and edit SOPs, logbooks, batch records, and Master Batch Records for accuracy and regulatory alignment.
• Participate in internal GMP audits and support customer and regulatory audits.
• Perform applicable ERP transactions.
• 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