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Quality Assurance Specialist

2 months ago

Hercules, California, United States X-Therma Inc. Full time
About X-Therma Inc.

X-Therma Inc. is a pioneering biotech company that specializes in developing innovative cold chain technology for the advancement of Regenerative Medicine. Our mission is to make safe and on-demand organs, engineered tissues, and cell & gene therapies available to patients in need.

Job Summary

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our Quality Control/Assurance Department. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our manufacturing process, from writing procedures to executing quality control for each manufacturing batch.

Key Responsibilities
  • Develop and implement Standard Operating Procedures (SOPs), forms, protocols, 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 to ensure compliance with regulatory requirements.
  • Review the production process from Bills of Materials to executed Master Batch Records to ensure accuracy and compliance.
  • 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.
Requirements
  • 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.
  • Thrive in an early-stage environment with a proactive attitude; no task is too big or too small for you.
  • 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.
Preferred Qualifications
  • Knowledge and experience in cGMP, preferably FDA and ISO 13485 requirements.
  • A self-driven, highly efficient, and outcome-focused attitude.
  • Team-oriented drive to contribute to improving organ transplantation and regenerative medicine.
What We Offer
  • Competitive base salary $60,000 to $80,000 annually.
  • ADP benefits, Health, vision, and dental benefits, with high family coverage.
  • 401(k) savings plan.
  • Employee Stock Option Plan.
  • And more.
About Us

X-Therma Inc. is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.