Kindeva Drug Delivery · 4 hours ago
Production Coordinator
Kindeva Drug Delivery is a company dedicated to making products that save lives and enhance patient well-being. The Production Coordinator will assist in manufacturing activities, ensure compliance with production documentation, and support continuous improvement initiatives within the production environment.
Manufacturing
Responsibilities
Performs GMP audits of the cleaning rooms and aseptic processing areas as required
Performs real-time review of production documentation (batch records, logbooks, etc.) for compliance on effective SOP
As needed, coach colleagues in cGMP (21 CFR 210 & 211) and cGMP (ALCOA & ALCOA +) when opportunities for improvement are found
Compose new or revise departmental SOPs as required
Reports any significant shift activities to Supervisor or Manager/TL
Ability to suggest effective corrective/preventative action
Assist Supervisor to confirm the necessary inventory on materials and sterile items used in the aseptic processing area are available
Assist with adherence to the production schedule by ensuring that the necessary documentation, machine parts, component and support materials are available inside the APA when required
Act as a resource for the site’s continuous improvement culture by propose ideas to reduce human error deviations and manufacturing improvements based on Six Sigma / Lean Manufacturing principles, IMEx, and be a member of cross-functional team as needed
Batch Record review; coordinate equipment maintenance and repairs with the Tech Services group ; coordinate with QC Lab for laboratory testing (as Required by the Production Supervisor); coordinate with Materials and Planning for scheduling of filling operations and ordering of materials
Support Filling Supervisor on daily activities and receive information on activities; and MQA for any quality issues/concerns
Support on data collection
Perform document issuance and reconciliation (controlled documents)
Train the personnel as require
Assists the Supervisor with special projects and other duties as assigned by Management
Qualification
Required
High School Diploma or Associates Degree required
1-3 years' work experience required and/or combination of education and experience
Effective written and oral communication skills required
Microsoft Applications, Compliance Wire, Trackwise, Inventory Control in D365
Demonstrated reading comprehension and writing proficiency at level that meets ‘role' and/or ‘test' requirements
Ability to effectively communicate within a diverse group resulting in desired outcomes
Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties
Use of eye protection, gloves and other PPE is required
Maintaining aseptic area certification may be required
Aseptic gowning procedures will be required
Practices and promotes safe working environment at all times
Preferred
Bachelor's degree preferred
Pharmaceutical or manufacturing experience highly desirable
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
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
Recent News
MarketScreener
2026-01-01
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