Kindeva Drug Delivery · 9 hours ago
Quality Assurance Specialist I
Lexington, KY
Full-time
Onsite
New Grad, Entry Level
0+ years expKindeva Drug Delivery is a company dedicated to making products that save lives and improve patient health. The Quality Assurance Specialist I will oversee and support pharmaceutical manufacturing operations, ensuring compliance with quality standards and regulations throughout the development and testing phases.
Manufacturing
Responsibilities
Supports on-shift manufacturing operations and activities including but not limited to real time auditing of production batch records, sampling and AQL, line clearances
Supports the development and maintenance of Quality Systems as appropriate
Leads continuous improvement objectives to assure compliance with DEA and FDA regulations
Advises senior management on findings and recommendations related to internal and external auditing
Manages deviation, OOS, CAPA and Change Control Systems:
Evaluate proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards
Participate in investigations and root cause analyses for deviations, OOS results, and audit findings
Ensure timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues
Reviews, and approves cGMP documentation including but not limited to procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents
Develops and maintains metrics and trending reports for Compliance-related activities
Reviews and approves product complaint investigations and assists with investigations
Performs activities associated with various one-time or on-going projects (from participation level to project manager)
Collaborates with departments and external suppliers regarding quality concerns
Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.)
Supports regulatory inspections and customer audits
Assists Manager with daily and project activities as needed
Other duties as assigned
Qualification
Required
Bachelor degree in a scientific discipline (preferred experience may be substituted for education)
At least 0-3 years Pharmaceutical/Medical Device cGMP quality experience
Knowledge of data integrity principles (ALCOA+) and compliance with 21 CFR Part 11 for electronic records
Knowledge of HPLC principles and ability to review data for accuracy and completeness
Knowledge of microbiological testing principles and ability to review data for accuracy and completeness
Ability to assess problems, to identify solutions, to plan and implement necessary changes
Ability to work well in a team-oriented environment
Well-developed communication and technical writing skills
Qualified to work with controlled substances
Experienced in leading and assisting in deviation investigations and implementation of appropriate CAPAs
Preferred
Experience in quality systems auditing (internal and/or external)
Familiarity with electronic QMS platforms (e.g., TrackWise, MasterControl,etc)
Experience in manufacturing aseptically filled, sterile products
Advanced knowledge of cGMP regulations and validation principles (e.g. FDA 21 CFR Part 820, ISO 13485, etc)
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
2026-01-16
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-16
MarketScreener
2026-01-01
Company data provided by crunchbase