Part-time Temp/consultant QA Gmp Auditor

3 weeks ago


San Diego, United States Poseida Therapeutics Inc Full time

Description:
**Please note that this is a part-time temporary/consultant position. Need is for 24 hours a week, 2 days a week expected to work onsite.

**Position Summary**

The GMP Auditor/Consultant is responsible for planning and conducting quality audits (Quality auditing oversight) related to GMP vendors and for qualifying vendors. This role will facilitate upcoming audits, support the development and revision to Quality Agreements and provide support for the supplier qualification program.

**Responsibilities**

These may include but are not limited to:

- Lead vendor and internal audits, conducting the audit planning and scheduling, audit scope development and execution of the audit including opening/closing activities and report preparation
- Schedule, prepare, and conduct Vendor Qualification
- Perform audits in accordance with Poseida standard operating procedures and regulatory requirements
- Communicating audit results to management and auditees through written audit reports
- Leading post-audit activities, assess audit findings and assist the business in identifying and developing CAPAs/ remediation options and prioritize their closure
- Updating Vendor Audit list including approved vendors
- Working with Poseida cross functional teams in identifying new vendors that require qualification and or audit activities
- Coordinating activities in support of the Vendor audit plan
- Other QMS/Compliance functions as assigned.

**Requirements**:
**Qualifications**:

- Minimum 8 years GMP auditing experience including raw material suppliers, third party service providers.
- Direct auditing experience required.
- Supplier quality management program experience required and QA/Compliance experience required.
- ASQ audit certification preferred.
- Limited travel required for audits.


  • QA Auditor

    2 weeks ago


    San Jose, United States PSC Biotech Full time

    Job DescriptionJob DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements....

  • Director, GMP QA

    2 weeks ago


    San Francisco, United States Meet Full time

    Title: Director, GMP QA Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. Company Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on...

  • Director, GMP QA

    2 weeks ago


    South San Francisco, United States Meet Full time

    Title: Director, GMP QA Company Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on cutting-edge research and development, they are dedicated to bringing transformative treatments to patients worldwide. We are partnered to recruit an...

  • Director, GMP QA

    3 weeks ago


    South San Francisco, United States Meet Full time

    Title: Director, GMP QACompany Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on cutting-edge research and development, they are dedicated to bringing transformative treatments to patients worldwide. We are partnered to recruit an...

  • Director, GMP QA

    3 weeks ago


    South San Francisco, United States Meet Full time

    Title: Director, GMP QACompany Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on cutting-edge research and development, they are dedicated to bringing transformative treatments to patients worldwide. We are partnered to recruit an...

  • Director, GMP QA

    3 weeks ago


    South San Francisco, United States Meet Full time

    Title: Director, GMP QACompany Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on cutting-edge research and development, they are dedicated to bringing transformative treatments to patients worldwide. We are partnered to recruit an...

  • Principal Auditor

    3 weeks ago


    San Diego, California, United States Sempra Full time

    Primary PurposeTo plan, scope, and identify objectives, resources, budget, and hours. Will conduct all phases of assigned multiple team audits, while assessing the work of Auditors and Sr. Auditors. Provide customers with high-quality value-added audit and consulting services for all Sempra, regulated and non-regulated, businesses.Duties and...

  • Principal Auditor

    3 weeks ago


    San Diego, California, United States Sempra Full time

    Primary PurposeTo plan, scope, and identify objectives, resources, budget, and hours. Will conduct all phases of assigned multiple team audits, while assessing the work of Auditors and Sr. Auditors. Provide customers with high-quality value-added audit and consulting services for all Sempra, regulated and non-regulated, businesses.Duties and...


  • South San Francisco, United States GQR Full time

    A biotech client in SSF in looking for a GMP Quality Consultant to join their team. The position is a 12 month contract, 20 hours per week in South San Francisco. ***Candidates must be local to the Bay Area*** Responsibilities would include: Assisting QA team with QMS implementation Supporting vendor/CMO oversight and audits supporting batch record review,...


  • South San Francisco, United States CareerBuilder Full time

    A biotech client in SSF in looking for a GMP Quality Consultant to join their team. The position is a 12 month contract, 20 hours per week in South San Francisco. ***Candidates must be local to the Bay Area*** Responsibilities would include: Assisting QA team with QMS implementation Supporting vendor/CMO oversight and audits supporting batch record review,...


  • South San Francisco, United States GQR Full time

    A biotech client in SSF in looking for a GMP Quality Consultant to join their team. The position is a 12 month contract, 20 hours per week in South San Francisco.***Candidates must be local to the Bay Area***Responsibilities would include:Assisting QA team with QMS implementationSupporting vendor/CMO oversight and auditssupporting batch record review, GMP...


  • South San Francisco, United States GQR Full time

    A biotech client in SSF in looking for a GMP Quality Consultant to join their team. The position is a 12 month contract, 20 hours per week in South San Francisco.***Candidates must be local to the Bay Area***Responsibilities would include:Assisting QA team with QMS implementationSupporting vendor/CMO oversight and auditssupporting batch record review, GMP...


  • South San Francisco, United States GQR Full time

    A biotech client in SSF in looking for a GMP Quality Consultant to join their team. The position is a 12 month contract, 20 hours per week in South San Francisco.***Candidates must be local to the Bay Area***Responsibilities would include:Assisting QA team with QMS implementationSupporting vendor/CMO oversight and auditssupporting batch record review, GMP...

  • Principal Auditor

    3 weeks ago


    San Diego, United States Sempra Full time

    Primary Purpose To plan, scope, and identify objectives, resources, budget, and hours. Will conduct all phases of assigned multiple team audits, while assessing the work of Auditors and Sr. Auditors. Provide customers with high-quality value-added audit and consulting services for all Sempra, regulated and non-regulated, businesses. Duties and...

  • Principal Auditor

    3 weeks ago


    San Diego, United States Sempra Full time

    Primary Purpose To plan, scope, and identify objectives, resources, budget, and hours. Will conduct all phases of assigned multiple team audits, while assessing the work of Auditors and Sr. Auditors. Provide customers with high-quality value-added audit and consulting services for all Sempra, regulated and non-regulated, businesses. Duties and...


  • South San Francisco, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.We are seeking a Senior Manager of GMP Quality...

  • Night Auditor

    5 days ago


    San Diego, United States Pacifica Hotel Company Full time

    And Responsibilities of the job include but are not limited to: - Maintain a friendly, cheerful and courteous demeanor at all times, while providing personalized service to hotel guests. - Communicate effectively with guests and fellow team members. Night Auditor, Auditor, Audit, Accounting, Hotel

  • QA Director

    2 weeks ago


    San Francisco, United States Red Kite Recruiting Full time

    We're working with a better-for-you meat processor looking to identify a driven QA Director to join their SQF facility in Northern California. My client is primarily retail but is expanding into foodservice as they continue to grow. The QA Director acts as the liaison between production, quality and regulatory. This person supports the facility and QA...


  • South San Francisco, United States Alumis Inc. Full time

    Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are seeking a Director of GMP Quality...


  • South San Francisco, United States Alumis Inc. Full time

    Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are seeking a Director of GMP Quality...