Gmp Quality Specialist - San Diego, United States - Poseida Therapeutics Inc

Poseida Therapeutics Inc

Verified Company

San Diego, United States

3 days ago

Posted by:

Mark Lane

beBee recruiter

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:

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 onthefloor 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 fastpaced 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

Who We Are and What We Do
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."