Quality Specialist II (GMP)

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 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 teamsReview executed production batch records and associated testing data to ensure the records meet cGMP expectationsWork with your Manager to ensure out of specification results and deviations are fully investigated and appropriate CAPAs are assignedReview of master batch production records and other batch documentation as requestedActively provide input at the QA project team meetingsComplete and maintain Quality trackers as assigned, leverage data within trackers to generate standardized metrics, as requestedLeverage Quality Risk Management principles in support of quality event management, change management, and process development activitiesSupport internal Quality System audits as requestedCollaborate with Manufacturing, Process Development, and Quality Control personnel to create, revise, and review Master Batch RecordsCreate, revise, and review SOPs, Forms, Work Instructions and other controlled documents within Poseida's QMS, as assignedPerform line clearance activities within a cleanroom (ISO classified) environmentCreate, issue, control, and reconcile finished good labels for clinical productPerform raw material release, Leukopak receipt, product shipment and other MQA support activities as assignedProvide QA on-the-floor support for internal manufacturing processes as assignedIdentify opportunities for improvement within the assigned roles and responsibilities and take initiative to drive the changeComplete other Quality Assurance based activities as assignedAlign daily actions with department goals and company cultureDrive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priorityFoster and embrace an environment of teamwork, accountability and responsibility that supports the manufacture of a quality productRequirements, 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 practicesBatch review/batch release experience requiredStrong understanding of Material Review Board and Change Control processesDetail oriented with excellent written and verbal communication skillsBasic computer skills in Excel, PowerPoint, and word processingAbility to effectively work independently, within prescribed guidelines, and as a team memberDemonstrated ability to work efficiently in a dynamic, complex and fast-paced team environmentAbility to support a flexible work schedule to accommodate the Poseida Manufacturing scheduleMust be able to achieve and retain gowning qualified statusMust be physically capable to lift 20 pounds and stand for periods up to 2 hoursQuality Specialist II Pay Rate:

$38.94/hour to $44.00/hourThe 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!

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