Kindeva Drug Delivery · 6 hours ago
Supervisor, Quality Assurance
St. Louis County, MO
Full-time
Onsite
Mid, Senior Level
3+ years expKindeva Drug Delivery is a company focused on making products that save lives, ensuring better health and well-being for patients around the world. The QA Supervisor – Aseptic will provide oversight to Quality Inspector colleagues and ensure compliance with aseptic processing principles, good documentation practices, and regulatory requirements.
Manufacturing
Responsibilities
Proficiency of internal manufacturing and quality assurance procedures as well as compliance and regulatory requirements
Proficiency in Batch Record reviews for conformance to established procedures and critical process parameters
Provide leadership and guidance to quality inspectors and ensure adequate coverage through dynamic scheduling for APA and Grade D/CNC areas throughout the shift
Ensure training is completed for direct reports
Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues
Ability to solve problems and suggest solutions when escalating
Ability to successfully don a sterile gown and complete gowning qualification requirements and maintain it to support critical aseptic processing areas (APA)
Participate in media fills as Quality Observer when needed
Initiate incidents in QTS as applicable
Train on performing line clearance / verification of critical areas
Perform daily on-line auditing in the APA to ensure the area is maintained in an audit ready state
Aid in Root Cause Analysis and identification of Preventive Actions to support manufacturing investigations
Assists in identifying continuous improvements of Standard Operating Procedures (SOPs) and Master Batch Records
Perform other Quality Assurance functions as needed
Attend and participate in daily shift huddles/Gemba meetings
Qualification
Required
Education: BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science related discipline. In lieu of a bachelor's degree an associate's degree with 2+ years of experience
Experience: Minimum 3 years of pharmaceutical experience or equivalent combination of education and experience
Proficiency of internal manufacturing and quality assurance procedures as well as compliance and regulatory requirements
Proficiency in Batch Record reviews for conformance to established procedures and critical process parameters
Provide leadership and guidance to quality inspectors and ensure adequate coverage through dynamic scheduling for APA and Grade D/CNC areas throughout the shift
Ensure training is completed for direct reports
Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues
Ability to solve problems and suggest solutions when escalating
Ability to successfully don a sterile gown and complete gowning qualification requirements and maintain it to support critical aseptic processing areas (APA)
Participate in media fills as Quality Observer when needed
Initiate incidents in QTS as applicable
Train on performing line clearance / verification of critical areas
Perform daily on-line auditing in the APA to ensure the area is maintained in an audit ready state
Aid in Root Cause Analysis and identification of Preventive Actions to support manufacturing investigations
Assists in identifying continuous improvements of Standard Operating Procedures (SOPs) and Master Batch Records
Perform other Quality Assurance functions as needed
Attend and participate in daily shift huddles/Gemba meetings
Must be able to work in a team environment and across interdepartmental teams
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short, or long term basis
Must have the ability to simultaneously multi-task across multiple capabilities, functions and manages competing priorities, including performing site and functional responsibilities, frequent e-mail and phone communications and attending multiple meetings and conference calls
Must have the ability to work effectively under and manage to strict production, time, and performance deadlines
Must be willing and able to work beyond the hours typically defined as a 'regular' workday, which may or may not include weekends and holidays
Preferred
Experience at an aseptic manufacturing site preferred
1 year of supervisory experience is preferred
Produces quality work with minimal guidance
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
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