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 Poseida’s passion - developing 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 Poseida Quality Assurance team welcomes you!

Position Summary:

Poseida Therapeutics, Inc. is seeking an exceptional candidate to join our Quality team in San Diego, CA. The Specialist Quality Assurance candidate will have Manufacturing Quality Assurance (MQA) related responsibilities to ensure Poseida’s starting materials, including Pipeline Products Support (PPS) materials and Clinical products meet cGMP requirements. This role reports to the Manager of Quality Assurance.

Responsibilities

Manufacturing Quality Assurance related activities include but are not limited to:

• Effectively communicate and collaborate with internal Quality Assurance, Manufacturing, Quality Control, Procurement, PPS and Facilities teams
• Review executed PPS and 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 Poseida’s 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 all QA line clearance activities 
• Participate in the establishment of raw material specifications
• Conduct routine inspection of warehousing areas for compliance with the raw material program 
• Perform raw material release, product shipment 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 2 plus years of relevant experience, GMP experience preferred (an equivalent combination of education and experience may be considered)
• Experience with a GMP raw materials program preferred.
• Knowledge of cGMP regulations 21 CFR Part 11, 210, 211 and good documentation practices 
• 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 Poseida 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

Quality Specialist Pay Rate: $29.81/hour to $37.50/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 

Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients’ lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.

At Poseida we put people first. Our team is passionate about improving patients’ lives through innovation. See what our team has to say about our culture:

“My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we’re doing here and there’s so much camaraderie. It feels like one big enthusiastic family.”

“My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude.”

As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today!