Intern, Quality

About Us:

Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T-cell therapies to treat cancers. Its core technology centers around its proprietary ARTEMIS® cell receptor platform and E-ALPHA® antibody discovery platform for the discovery and development of potentially safer and more effective T-cell therapies for the treatment of solid tumors and hematologic malignancies. The company currently has two clinical programs, ET140203 (ARYA-1 for adults and ARYA-2 for pediatrics) and ECT204 (ARYA-3), in Phase I/II US trials in patients with advanced liver cancer.

Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit www.eurekatherapeutics.com. ARTEMIS and E-ALPHA are registered trademarks owned by Eureka.

Job Description:

The Quality Assurance (QA) Associate works in the Clinical T-Cell Manufacturing (CTCM) group as part of the Quality Assurance team. He/she will join an experienced team, supporting QA, and manufacturing as applicable.

Responsibilities:

• Learns and applies GMP Good Documentation Practices (GDP).
• Conducts environmental monitoring (EM), including sampling, incubation, analysis, and data entry with trained staff.
• Prepares training materials related to GDP, microbial control, and others if necessary.
• Develops posted information work instructions supported by pictures and diagrams for material transfer, gowning, and other processes as needed.
• Performs minor document updates using the change management system.
• Files records electronically and prepares for physical archival.
• Conducts quality review of cleaning, facility access, and environmental monitoring records to ensure GDP.
• Qualifies pens to be used for GMP purposes.
• General administrative support for QA upon request.
• Evaluates Microsoft PowerApps and/or Bluecord for EM data workflow and implements if appropriate.
• Evaluates equipment inventory excel sheet and ensures that information is current, accurate, and complete and that all equipment has an associated ID.
• Answers incoming calls.
• Other duties as assigned.

Minimum Qualifications:

• Associate’s degree or equivalent experience.
• Knowledge of cGMP manufacturing and related regulations and cGMP documentation practices is a plus.
• Good interpersonal, verbal and written communication skills.
• Proficiency with standard software is required (e.g. Microsoft Office)
• Ability to work independently.

For the best fit, the candidate should be a fast learner who is detail-oriented and results-driven with outstanding organizational skills, and a team player with strong interpersonal and communications skills and capable of working collaboratively with colleagues. The candidate should be comfortable in a fast-paced environment, able to adjust workload based upon changing priorities and willing to take additional responsibilities outside of initial job description.

To Apply:

Please submit your resume or CV and cover letter to Jobscore. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.

If you are a recruiter or placement agency, please do not submit resumes to any employees at Eureka Therapeutics, Inc. prior to having a signed agreement. Eureka Therapeutics is not liable for and will not pay agency fees for candidates submitted by any agency other than its approved recruitment partners. Furthermore, any resumes sent to us without an agreement in place will be considered your company’s gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.