Quality Assurance Specialist Role at Kindeva Drug Delivery USA
Looking for a rewarding qa job in pharmaceuticals? Kindeva Drug Delivery is hiring a Quality Assurance Specialist in Lexington, KY. Join a team that ensures patient safety and product quality while advancing your career in cGMP compliance and pharmaceutical operations.
Job Details:
- Job Title: Quality Assurance Specialist I
- Location: Lexington, KY, USA
- Job Family: D – Quality – Quality Assurance
- Job Function: D – Quality
- Pay Type: Salary
- Req #: 2365
- Work Mode: Onsite (#LI-Onsite)
About the Company:
Kindeva Drug Delivery develops products that improve patient health and save lives. With a strong commitment to quality, innovation, and safety, Kindeva Drug Delivery ensures compliance with global regulatory standards while advancing pharmaceutical manufacturing practices. Explore more QA job offers.
Educational Requirements:
- Bachelor’s degree in a scientific discipline (preferred)
- Equivalent experience may be considered in lieu of education
Key Responsibilities of Quality Assurance Specialist Role:
- Provide quality oversight during pharmaceutical manufacturing and testing
- Audit batch records, raw materials, intermediates, and final products
- Manage deviations, OOS, CAPA, and Change Control systems
- Review and approve cGMP documentation and procedures
- Collaborate with internal departments and external suppliers
- Participate in internal and external audits and regulatory inspections
- Lead or assist in continuous improvement initiatives
Skills Required for Quality Assurance Specialist Role:
- Knowledge of cGMP regulations and validation principles (FDA 21 CFR Part 820, ISO 13485)
- Understanding of ALCOA+ data integrity principles and 21 CFR Part 11 compliance
- Experience with HPLC and microbiological testing principles
- Ability to assess problems, implement solutions, and ensure regulatory compliance
- Strong communication, technical writing, and team collaboration skills
- Experience with electronic QMS platforms (e.g., TrackWise, MasterControl)
- Experience leading deviation investigations and CAPA implementation
Benefits of the Quality Assurance Specialist Role:
- Opportunity to work in a mission-driven pharmaceutical company
- Hands-on experience with cGMP compliance and QA systems
- Career growth in quality assurance and pharmaceutical manufacturing
- Participation in audits, compliance assessments, and regulatory inspections
- Work on projects that impact patient safety and product quality
