200+ applicants

Company

Original Job Post

X-Therma Inc. · 1 week ago

Quality Associate

Hercules, CA

Full-time

Onsite

Entry Level

$60K/yr - $80K/yr

1+ years exp

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BiotechnologyHealth Care

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Responsibilities

Write SOP, forms, protocol, and work instructions as assigned.

Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health, and safety requirements.

Participate in Vendor and internal audits.

Review the production process from Bills of Materials to executed Master Batch Records.

Support product shipping activities and perform quality-related oversight and verifications.

Achieve and maintain clean side gown and sterile side gown qualifications.

Achieve and maintain Class A qualification.

Perform laboratory and equipment clearances.

Participate in Media Fill and gowning qualification.

Participate in Environmental Monitoring execution.

Perform basic testing for Quality Control release, stability, and raw material release.

Assist in the transition of new products from the R&D phase to production.

Be part of the documentation routines on the path to a certified Class II medical device.

Perform any other tasks/duties as assigned by management.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

FDA regulationsCleanroom settingsQuality controlMicrosoft WordMicrosoft ExcelEnglish fluencyLaboratory workPhysical liftingOn-site positionProblem-solvingInterpersonal skillsCommunicationCollaborationConflict managementTeamworkCGMPFDAISO 13485

Required

Associates or Bachelor’s Degree in science/ medical device industry or equivalent in a related field.

Minimum 1 year work experience in FDA regulated environment or similarly regulated area is preferred.

Experience with cleanroom settings (quality or manufacturing) preferred.

Experience with quality control - environmental monitoring preferred.

Intermediate skills in Microsoft Word and Excel are required.

Excellent organizational, interpersonal and communication skills (written and oral) required.

Ability to take feedback and provide feedback constructively within a team-oriented work environment.

A strong work ethic and self-motivation to deliver results within timeline

Strong analytical and problem-solving skills.

Ability to work independently with a focus on quality and results.

Excellent interpersonal skills and competencies in collaboration, conflict management and teamwork.

Fluent in English.

Must be able to work in a laboratory and office setting without prohibitive limitations.

Able to physically lift up to 50 lbs and assist with moving/installing laboratory equipment

Prolonged periods sitting at a desk and working on a computer.

This is an on-site position.

Preferred

Experience in cGMP, preferably FDA and ISO 13485 requirements

Benefits

ADP benefits

Health, vision, and dental benefits, with high family coverage

401(k) savings plan

Employee Stock Option Plan

Company

X-Therma Inc.

X-Therma Inc. is solving unmet legacy needs in the storage of biological products using convergent biomimetic nanotechnology.

Founded in 2014

Richmond, California, USA

11-50 employees

https://x-therma.com

H1B Sponsorship

X-Therma Inc. 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

Trends of Total Sponsorships

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