Quality Associate

1 week ago

Hercules, California, United States X-Therma Inc. Full time
Quality Associate - Biotech Pioneer

X-Therma Inc. is a venture-backed biotech company pioneering ground-breaking cold chain technology. We're seeking a Quality Associate to support our mission to advance Regenerative Medicine and make safe and on-demand organs, engineered tissues, and cell & gene therapies available to patients in need.

Key Responsibilities:
  • Write 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.
  • Review production processes 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.
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.

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.

  • Quality Associate

    1 month ago

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

    Quality Associate Job DescriptionX-Therma Inc. is a pioneering biotech company that is revolutionizing the field of regenerative medicine. We are seeking a highly motivated and detail-oriented Quality Associate to join our Quality Control/Assurance Department.Key Responsibilities:Develop and implement quality procedures and protocols to ensure compliance...

  • Quality Assurance Specialist

    3 weeks ago

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

    Quality Associate Job DescriptionX-Therma Inc. is a pioneering biotech company that is revolutionizing the field of regenerative medicine. We are seeking a highly motivated and detail-oriented Quality Associate to join our Quality Control/Assurance Department.Key Responsibilities:Develop and implement quality control procedures to ensure the integrity of our...

  • Quality Assurance Specialist

    1 week ago

    Hercules, California, United States Tucker Parker Smith Group (TPS Group) Full time

    Job Title: Quality Control AnalystJoin the Tucker Parker Smith Group (TPS Group) team as a Quality Control Analyst, supporting our client, a medical device company, in their quest for excellence in quality control.Job Summary:We are seeking a highly motivated and detail-oriented Quality Control Analyst to join our team. As a Quality Control Analyst, you will...

  • Quality Control Specialist

    2 weeks ago

    Hercules, California, United States Yoh Full time

    {"Responsibilities": "Key ResponsibilitiesPerform quality control testing on incoming and manufactured materials to support release into inventory.Document testing activities and results accurately following good documentation practices to ensure adherence to ISO13485 requirements.Support quality control activities towards PCR reagents and consumable...

  • Quality Assurance Specialist II

    4 days ago

    Hercules, California, United States TPS Group Company Full time

    Job Responsibilities:Support batch release for LSG mfg sites.Support Veeva integration for NorCal (Change Control, Nonconformance Management).Verification of Change Control activities.Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue).Audit preparedness, to reduce audit findings.Requirements:Associate...

  • Laboratory Quality Control Specialist

    1 week ago

    Hercules, California, United States Yoh Services LLC Full time

    Job Summary:We are seeking a highly skilled Laboratory Quality Control Specialist to join our team at Yoh Services LLC. As a Laboratory Quality Control Specialist, you will be responsible for performing quality control testing on incoming and manufactured materials to support release into inventory.Key Responsibilities:Perform quality control testing on...

  • Quality Control Specialist

    4 days ago

    Hercules, California, United States AbD Serotec Full time

    Job SummaryWe are seeking a highly skilled Quality Control Specialist to join our team at AbD Serotec. As a Quality Control Specialist, you will be responsible for inspecting incoming raw materials, electronic, and mechanical components to ensure they meet design specifications.Key ResponsibilitiesPerform manual and automated inspection of raw materials,...

  • Laboratory Quality Control Specialist

    4 days ago

    Hercules, California, United States Yoh Full time

    We are seeking a highly skilled QC Specialist I to join our team at Yoh. This is a contract opportunity with a possibility of extension or conversion.Key Responsibilities:Perform quality control testing on incoming and manufactured materials to support release into inventory.Document testing activities and results accurately following good documentation...

  • Laboratory Associate

    2 weeks ago

    Hercules, California, United States TCWGlobal Full time

    Job Title: Laboratory AssociateJoin our team as a Laboratory Associate and contribute to the development of state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities worldwide.Key Responsibilities:Perform quality control and quality assurance tasks, including functional testing and documentation.Prepare and...

  • Software Quality Assurance Engineer

    1 week ago

    Hercules, California, United States Bio-Rad Laboratories Full time

    We are seeking a talented and passionate Software Quality Assurance Engineer to join our exciting team. As a key member of our team, you will have the opportunity to make a significant impact on the design, architecture, and implementation of innovative cloud platforms used for life science research.The cloud platform connects with Bio-Rad instruments and...

  • Laboratory Associate

    4 days ago

    Hercules, California, United States TCWGlobal Full time

    Job Title: Laboratory Associate - Manufacturing SpecialistJob Summary:We are seeking a highly motivated Laboratory Associate - Manufacturing Specialist to join our team at TCWGlobal. As a key member of our Quality Control team, you will be responsible for ensuring the quality of our life science research products.Responsibilities:- Conduct quality control...

  • Multi-Purpose Store Associate

    4 days ago

    Hercules, California, United States Lucky Supermarkets Full time

    Proud to be California's largest regional, full-service grocery chain, Lucky Supermarkets and its 13,000 Associates take extra care to provide customers with the freshest quality products at a great value.Our dedication to customers and community is reflected in the connections we've made in the neighborhoods we've served for over 70 years.The Save Mart...

  • Associate Director OEM/Resale Procurement Lead

    2 weeks ago

    Hercules, California, United States Bio-Rad Laboratories Full time

    Job Title:Associate Director OEM/Resale ProcurementJob Summary:We are seeking an experienced Associate Director OEM/Resale Procurement to lead our global procurement team and drive strategic procurement planning, supply chain optimization, cost management, risk mitigation, and supplier relationship management.Key Responsibilities:Develop and execute...

  • Store Associate

    2 weeks ago

    Hercules, California, United States Lucky Supermarkets Full time

    About UsThe Save Mart Companies operate a chain of grocery stores in California and Western Nevada, providing customers with a wide range of products and services. Our company values its employees and the communities it serves, and we are committed to making a positive impact in the neighborhoods we operate in.Job SummaryWe are seeking a highly motivated and...

  • Clinical Nurse II

    1 week ago

    Hercules, California, United States Alameda Health System Full time

    Job Summary:As a Clinical Nurse II at Alameda Health System, you will provide high-quality patient care to patients, including medications and treatment. You will plan, implement, and evaluate patient care and perform related duties as required. This is a journey-level class where incumbents have had the required professional nursing experience and are...

  • Culinary Professional

    1 month ago

    Hercules, California, United States Compass Group Careers Full time

    Job OverviewWe are seeking a skilled Culinary Professional to join our team at Compass Group Careers. As a key member of our kitchen staff, you will be responsible for preparing high-quality food items according to standardized recipes and instructions.Key ResponsibilitiesFood Preparation: Prepare high-quality food items according to standardized recipes and...

  • Customer Service Representative

    2 weeks ago

    Hercules, California, United States Lucky Supermarkets Full time

    About UsThe Save Mart Companies operate a network of stores in California and Western Nevada, providing customers with a wide range of products and services. Our team of 13,000 Associates is dedicated to delivering exceptional customer experiences and building strong relationships with the communities we serve.Job SummaryWe are seeking a highly motivated and...

  • Die Cast Operations Manager

    2 weeks ago

    Hercules, California, United States Nelson Connects Full time

    Die Cast Manager Job DescriptionWe are seeking a highly skilled and experienced Die Cast Manager to join our team at Nelson Connects.Key Responsibilities:Oversee die casting and trim operations, ensuring efficient production and high-quality output.Develop and optimize die casting processes from start-up to mass production, minimizing waste and maximizing...

  • QC Specialist I

    2 weeks ago

    Hercules, California, United States Yoh, A Day & Zimmermann Company Full time

    Job OverviewWe are seeking a highly skilled QC Specialist I to join our team at Yoh, a Day & Zimmermann Company. This is a contract opportunity with a possibility of extension or conversion.The successful candidate will have a bachelor's degree or equivalent in a life science (Chemistry, Biology) or related field, with 0-2 years of experience in a general...

  • Production Technician III

    2 weeks ago

    Hercules, California, United States AbD Serotec Full time

    Job SummaryWe are seeking a highly skilled Production Technician III to join our team at Bio-Rad Laboratories, Inc. in Hercules, CA. As a key member of our Global Supply Chain's Manufacturing team, you will play a crucial role in producing specialized life science products essential for researchers and scientists striving for healthcare breakthroughs and...