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 is seeking an exceptional candidate to join our Quality team in San Diego, CA. The Sr. Specialist, Quality Assurance candidate will have Manufacturing Quality Assurance (MQA) related responsibilities to ensure Poseida's starting materials and Clinical products that are GMP manufactured meet cGMP requirements. In addition, this person will be responsible for the disposition of Pipeline Products Support (PPS) materials. This role reports to the Sr. 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, and Facilities teams
• Review executed production batch records and associated testing data to ensure the records meet cGMP expectations
• Work with your Manager to ensure out of specification results and deviations are fully investigated and appropriate CAPAs are assigned
• Review of master batch production records and other batch documentation as requested
• Actively provide input at the QA project team meetings
• Complete and maintains Quality trackers as assigned, leverage data within trackers to generate standardized metrics, as requested
• Leverage Quality Risk Management principles in support of quality event management, change management, and process development activities
• Support internal Quality System audits as requested
• Collaborate with Manufacturing, Process Development, and Quality Control personnel to create, revise, and review Master Batch Records
• Creation, revision, and review of SOPs, Forms, Work Instructions and other controlled documents within Poseida's QMS, as assigned
• Perform line clearance activities within a cleanroom (ISO classified) environment
• Create, issue, control, and reconcile finished good labels for clinical product
• Perform raw material release, Leukopak receipt, product shipment and other MQA support activities as assigned
• Provide QA on-the-floor support for internal manufacturing processes as assigned
• Identify opportunities for improvement within the assigned roles and responsibilities and take initiative to drive the 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, Knowledge, Skills and Abilities:

• Bachelor's or Master's degree in life sciences or a related field with 5+ years of relevant experience in a QA role. GMP/GxP experience preferred. (An equivalent combination of education and experience may be considered.)
• Clear understanding of cGMP regulations 21 CFR Part 11, 210, 211 and good documentation practices
• Batch review/batch release experience required
• Strong understanding of Material Review Board and Change Control processes
• Detail oriented with excellent written and verbal communication skills
• Basic computer skills in Excel, PowerPoint, and word processing
• Ability to effectively work independently, within prescribed guidelines, and as a team member
• Demonstrated ability to work efficiently 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 gowning qualified status
• Must be physically capable to lift 20 pounds and stand for periods up to 2 hours

Sr Specialist, Quality Assurance: $46.15/hour to $50.48/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!

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.