Quality Control Stability Coordinator jobs in United States
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Swiss American CDMO ยท 16 hours ago

Quality Control Stability Coordinator

positionCarrollton, TX
timeFull-time
remoteOnsite
seniorityEntry Level
date2+ years exp

Swiss American CDMO is seeking a Quality Control Stability Coordinator to manage the maintenance and reporting of stability testing through external laboratories. The role involves administrative duties, document management, and ensuring compliance with protocol requirements for stability studies.

Consumer GoodsManufacturing
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H1B Sponsor Likelynote

Responsibilities

Use electronic document systems to search, scan, name and file documents, including the assignment of protocol numbers for stability
Prepare documents and/or reports on behalf of the QC Stability Supervisor
Learn new processes and procedures
Maintain annual stability tracking list and request protocols for all studies required products
Ensure that all open stability protocols are executed per the protocol requirements
Provide necessary training to employees on protocol requirements to ensure accurate execution of protocol requirements
Review stability reports and initiate origination of all Non-Conformances (NCRs) for stability Out of Specification (OOS) results
Organize all in-process stability protocols and provide a weekly update on status and/or upcoming protocol activity as required
Coordinate the sampling and submission of stability samples to external laboratories as required by applicable stability protocols, including reviewing production schedule for stability sample requirements
Coordinate testing of returned samples from external laboratory for testing, as necessary
Request quotes from external laboratory for stability studies
Attending gate meetings, as necessary, to update internal stability testing status and requirements
Other duties may be assigned

Qualification

Regulated environment experienceProblem-solving skillsOrganizational skillsCommunication skillsTeam collaboration

Required

Experience working in a regulated environment
Strong problem-solving skills and a hands-on approach to problem solving
Highly proficient organizational skills which contribute to the ability to efficiently multi-task several objectives at the same time
Excellent organizational, interpersonal, collaborative, and verbal/written communication skills
A willingness to work as a contributing member of a dynamic team of individuals
High school diploma or general education degree (GED); or two years related experience and/or training in a QA/QC position; or equivalent combination of education and experience

Company

Swiss American CDMO

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Swiss American CDMO is a developer and manufacturer of topical skin and wound care products.
dateFounded in 1988
location
Carrollton, Texas, USA
people-size201-500 employees
web-link
http://www.swissamericancdmo.com/

H1B Sponsorship

Swiss American CDMO 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
2022 (3)

Funding

Current Stage
Growth Stage

Leadership Team

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Komel Grover
President & CEO
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Company data provided by crunchbase