Poseida Therapeutics is seeking an exceptional candidate to join our Quality team in San Diego, CA. The 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 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 2+ 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

Quality Specialist II Pay Rate: $38.94/hour to $44.00/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.