Quality Assurance Specialist

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

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. QA Specialist I collaborates with cross-functional teams to maintain compliance and contribute to continuous improvement initiatives.

• 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 elevate 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 / Master Batch Records.
• Perform ERP transactions, as applicable.
• 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.

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science‑related discipline or a minimum of 1 year experience in the pharmaceutical or related industry.
• 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.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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