Quality Associate

2 weeks ago

Hercules, United States X-Therma Inc. Full time

**Quality Associate**

**Hercules CA | On-Site**

Entry Date: 15 JUNE 2024

X-Therma, a venture backed biotech company pioneers ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, and cell & gene therapies to patients in need. X-Therma collaborates with renowned research institutions such as Lawrence Berkeley National Laboratory and Johns Hopkins University and is supported with significant funding from the US Department of Defense, National Science Foundation, California Institute of Regenerative Medicine, etc.

X-Therma technology greatly improves cold-chain logistics and is an **FDA Breakthrough Device** to end the organ waiting list in a long-overlooked market. This is a paradigm shift that could make worldwide organ sharing possible and eliminate organ discard. Immediately, the technology could resolve current bottlenecks in Regenerative Medicine biomanufacturing and processing and allow “off-the-shelf" living medicines in this hyper-growth space.

**Joining Team Excellence**:
We have a bold vision to create something great that has never been done before: We are wary of what could go wrong, but obsessed with what can go right. We are mission-driven, intellectually honest and relentless learners, ambitious, courageous, and extraordinarily persistent. “Giving up” does not exist in our vocabulary. We respect and support each other to get better every day and make the world a better place. We are in the San Francisco East Bay in Hercules, not only known for its beautiful scenery and comfortable weather all year round, but also you can truly embrace the breath of innovation and dream building spirit of San Francisco’s Biobay.

To strengthen our growing team, we are looking for a **Quality Associate in the Quality Control/Assurance Department**. You will support ensuring the quality of the entire manufacturing process, from writing procedures, reviewing Master Batch Records, ensuring the Quality of the production and executing the quality control for each manufacturing batches. You will ensure all processes and products meet specifications and that products are produced in accordance with GMP requirements. You will participate in all aspects of the exciting creation of the Quality Systems.

**What’s in it for you?**

You will have a great opportunity to contribute to groundbreaking, life-saving products.You will be part of a team producing our novel life-saving molecules and solutions. This role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives within the most urgent priorities.

**What you will do**:

- 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 of 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.

**Requested Qualifications**:

- 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 mo

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