Manufacturing Quality Assurance Associate at Poseida Therapeutics Inc

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Mar, 26

Salary

50.38

Posted On

05 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP, Communication, Collaboration, Attention to Detail, Document Review, Batch Release, SOP Creation, Teamwork, Problem Solving, Cleanroom Procedures, Manufacturing Support, Initiative, Flexibility, Computer Skills, Dynamic Environment

Industry

Biotechnology Research

Description

Description Your Impact: You will be an integral part of a friendly Quality Assurance Team that is dedicated, agile, and collaborative. In this role, you will work on-site directly with all GMP related functional teams that are committed to delivering quality products to our clinical patients. Your talents and expertise will directly contribute to the passion to develop innovative therapies with the capacity to cure. You will learn and advance in your career as this group is forward-thinking and fully supportive of career development. If you are an individual that is driven to make a difference, have a strong work ethic, and you want to be a part of an exciting bigger picture, the Quality Assurance team welcomes you! Position Summary: We are seeking an exceptional candidate to join our Quality team in San Diego, CA. The Manufacturing Quality Assurance Associate candidate will have Manufacturing Quality Assurance (MQA) related responsibilities to ensure Poseida’s starting materials and Clinical products meet cGMP requirements. This role reports to the Senior Quality Assurance Specialist. Responsibilities include but are not limited to: Effectively communicate and collaborate with internal Quality Assurance, Manufacturing, Quality Control, Procurement, and Facilities teams Review executed production batch records and associated testing data to ensure the records meet cGMP expectations Participate in QA team meetings Supports the use of and maintains Quality trackers as assigned Participate in the creation, revision, and review of basic SOPs, Forms, Work Instructions and other controlled documents within the QMS, as requested Qualify for and perform clean room (ISO classified) gowning for all QA on-the-floor support activities for internal manufacturing processes Perform QA line clearance activities Perform duties related to the raw material program, and other MQA support activities as assigned Identify opportunities for improvement within the assigned roles and responsibilities and take initiative to communicate and drive positive change Complete other Quality Assurance based activities as assigned Align daily actions with department goals and company culture Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority Fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product Requirements Requirements, Knowledge, Skills and Abilities: A minimum of a Bachelor’s degree in life sciences or a related field with a minimum of 2 years of relevant experience, GMP/GxP experience preferred (an equivalent combination of education and experience may be considered) Knowledge of cGMP of FDA, ICH and EU regulations Controlled document review and /or batch release experience preferred Basic understanding of Deviations, CAPAs and Change Control processes Detail oriented with strong written and verbal communication skills Basic computer skills in Excel, PowerPoint, and word processing Ability to work independently, within prescribed guidelines, and as a team member Demonstrated ability to work effectively in a dynamic, complex and fast-paced team environment Ability to support a flexible work schedule to accommodate the Manufacturing schedule Must be able to achieve and retain cleanroom (ISO classified) gowning qualified status Must be physically capable to lift 20 pounds and stand for periods up to 2 hours Manufacturing Quality Assurance Associate Pay Rate: $27.13/hour to $50.38/hour The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc. Who We Are and What We Do Poseida Therapeutics was acquired by Roche in early 2025 and is now part of the Roche Group. Poseida is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. Our people are as important as our cutting-edge technology. That’s why we invest in offering excellent career development opportunities to our employees, as well as highly competitive compensation and comprehensive benefits. We are committed to giving employees the resources they need to thrive, personally and professionally. Within the Roche organization, a healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Recruitment Fraud Alert Alert: Beware of Employment Scams Poseida Therapeutics, Inc. has received reports of employment-related scams. These scams have appeared in forms of false job advertisements and/or unsolicited contacts via communication/chat platforms, phone, email or text from individual(s) claiming to be or represent Poseida’s Human Resources team. Be advised that Poseida Therapeutics does not extend unsolicited employment offers. Furthermore, Poseida Therapeutics does not request payment information or charge prospective employees with any fees during the recruitment process. If you would like to pursue employment opportunities with Poseida Therapeutics, Inc., please visit our official careers website https://poseida.com/careers-culture/ or official Poseida Therapeutics LinkedIn page. Job postings that do not link directly to our careers website or official Poseida LinkedIn page are not legitimate and might be fraudulent. You may report fraudulent job advertisements or contacts via our Contact Us page at https://poseida.com/contact-us/ and select the subject “Careers.” If you have been defrauded or suspect identity theft as a result of an employment scam, please contact your local law enforcement agency for guidance.

Responsibilities

The Manufacturing Quality Assurance Associate will ensure that starting materials and clinical products meet cGMP requirements. Responsibilities include reviewing production batch records, participating in QA meetings, and supporting quality trackers and documentation.