Kindeva Drug Delivery · 18 hours ago
Quality Assurance Specialist I
St. Louis County, MO
Full-time
Onsite
Entry Level
1+ years expKindeva Drug Delivery is dedicated to creating products that enhance health and save lives. The QA Specialist I role involves providing quality oversight and compliance support for manufacturing processes, ensuring adherence to regulatory standards and continuous improvement initiatives.
Manufacturing
Responsibilities
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 escalate 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
Participates in internal GMP audits and supports customer and regulatory audits
Assists in review and editing of SOPs / Master Batch Records
Performs 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
Qualification
Required
Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 1 years 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
Preferred
Certified Quality Auditor (CQA) Certification preferred
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
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2026-01-16
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2026-01-01
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