Quality and Compliance Specialist II/III

2 weeks ago

Vacaville, United States Polaris Pharmaceuticals Inc. Full time

Role Summary


The Quality & Compliance Specialist II/III is responsible for establishing and maintaining quality agreements with suppliers and laboratories, maintaining supplier qualification through audits and questionnaires, evaluating change notifications from suppliers, and reporting on the supplier/material qualification status. They may also be responsible for conducting internal audits, participating in third-party audits, participating in and/or leading efforts towards site-preparedness/readiness for regulatory inspections. Additionally in this role, they will create schedules, select/manage audit team members, and manage work of self and team members.


PRIMARY ROLE RESPONSIBILITIES


  • Establish and maintain quality agreements with suppliers and contract test laboratories.
  • Maintain supplier qualification through audits and questionnaires, including managing, scheduling, conducting audits of suppliers and contract test laboratories.
  • Lead and conduct internal quality audits in manufacturing, QC, facilities, warehouse, and utility areas according to established procedures, cGMP and company standards.
  • Evaluate audit findings and ensure the implementation of appropriate corrective actions.
  • Train auditors according to established procedures, cGMP and company standards.
  • Review batch records, in-process documents, analytical data, and other documentation to ensure compliance with corresponding procedures, cGMP and company standards.
  • Assist as needed in generation, review, and approval of protocols, reports, and other documents for regulatory submissions.
  • Participate in and/or host third-party audits.
  • Participate in and/or lead efforts towards site-preparedness/readiness for regulatory inspections (including PAI/PLI).
  • Prepare/present reports to stakeholders (e.g. Executives, Quality Review Board, Management, etc.).


SKILLS


  • Sound knowledge of cGMPs
  • Excellent written and verbal communication skills, including the ability to tailor communications to all levels in the organization and prepare appropriate updates to senior management / executives.
  • Strong interpersonal and leadership skills, along with adaptability, integrity, self-awareness, collaboration, and advocating for continuous improvement.
  • Must be able to prioritize a variety of competing tasks.


QUALIFICATIONS


Education/Experience:

  • B.S./B.A. in science-related field plus 6-8 years of related work experience in an FDA- regulated GMP environment, or
  • M.S. in science-related field plus 3-6 years of related work experience in an FDA-regulated GMP environment.
  • Experience with cGMP environments and quality systems is required.
  • CQA or other auditor qualification / certification is preferred.
  • Experience with hosting audits and interacting with health authority agencies is a plus.

  • Validation Engineer III

    4 weeks ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC is actively looking for a Validation Engineer III in Vacaville, CA area! 8-month contract with possible extensions! Benefits include medical, dental, vision, and life insurance Pay Rate: $76.00-$81.00/hour.This is an onsite role; candidate should be local. Primarily responsible for the support and execution of laboratory equipment qualification and...

  • Validation Engineer III

    4 weeks ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC is actively looking for a Validation Engineer III in Vacaville, CA area! 8-month contract with possible extensions! Benefits include medical, dental, vision, and life insurance Pay Rate: $76.00-$81.00/hour.This is an onsite role; candidate should be local. Primarily responsible for the support and execution of laboratory equipment qualification and...

  • Validation Engineer III

    2 days ago

    Vacaville, United States BEPC Incorporated Full time

    BEPC is actively looking for a Validation Engineer III in Vacaville, CA area! 8-month contract with possible extensions! Benefits include medical, dental, vision, and life insurance Pay Rate: $76.00-$81.00/hour. This is an onsite role; candidate should be local. Primarily responsible for the support and execution of laboratory equipment qualification and...

  • US_Validation Engineer III

    3 weeks ago

    Vacaville, United States Apollo Professional Solutions Full time

    Job Description Validation Engineer Location: Vacaville, CA Hourly rate: $63.00 - $81.00 Contractor benefits: Medical, Vision, Dental, 401k Description: •Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and corporate...

  • Validation Engineer III

    3 weeks ago

    Vacaville, United States LanceSoft Full time

    Qualifications Minimum of 1 year of hands-on experience in computer system validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports Proven track record in validation and qualification of complex computer systems Thorough knowledge of...

  • Senior Validation Engineer

    3 days ago

    Vacaville, United States BEPC Incorporated Full time

    BEPC has an open position for a Validation Engineer III in Vacaville, CA!! Contract W2 Period: 8-month contract with possibilities for extensions. Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life Insurance This is an onsite role; candidate should be local. Primarily responsible for the support and execution of laboratory equipment qualification...

  • Senior Validation Engineer

    4 weeks ago

    Vacaville, United States TalentBurst, an Inc 5000 company Full time

    Title: Validation Engineer III, Req#: ROCGJP00026009 Location: Vacaville, CA (100% onsite) Duration: 8 months Contract Job Description:Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and the client’s corporate...

  • Senior Validation Engineer

    4 weeks ago

    Vacaville, United States TalentBurst, an Inc 5000 company Full time

    Title: Validation Engineer III, Req#: ROCGJP00026009 Location: Vacaville, CA (100% onsite) Duration: 8 months Contract Job Description:Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and the client’s corporate...

  • Senior Validation Engineer

    4 weeks ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Validation Engineer III in Vacaville, CA!!Contract W2 Period: 8-month contract with possibilities for extensions.Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life InsuranceThis is an onsite role; candidate should be local.Primarily responsible for the support and execution of laboratory equipment qualification...

  • Senior Validation Engineer

    4 weeks ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Validation Engineer III in Vacaville, CA!!Contract W2 Period: 8-month contract with possibilities for extensions.Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life InsuranceThis is an onsite role; candidate should be local.Primarily responsible for the support and execution of laboratory equipment qualification...

  • Senior Validation Engineer

    1 week ago

    Vacaville, United States BEPC Incorporated Full time

    BEPC has an open position for a Validation Engineer III in Vacaville, CA!! Contract W2 Period: 8-month contract with possibilities for extensions. Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life Insurance This is an onsite role; candidate should be local. Primarily responsible for the support and execution of laboratory equipment qualification...

  • Customer Service Specialist

    4 days ago

    Vacaville, United States Mariani Packing Full time

    Job Opportunity: Customer Service Specialist Pay Rate – $23.47 – $28.16 Come Join us and Grow with our Family! At Mariani, we believe that family comes first! We understand work is only part of what makes life rewarding. If you enjoy working in a flexible, respectful, collaborative environment where community members embrace change and seek continuous...

  • Customer Service Specialist

    1 week ago

    Vacaville, United States Mariani Packing Full time

    Job Opportunity: Customer Service SpecialistPay Rate – $23.47 – $28.16Come Join us and Grow with our Family! At Mariani, we believe that family comes first! We understand work is only part of what makes life rewarding. If you enjoy working in a flexible, respectful, collaborative environment where community members embrace change and seek continuous...

  • Customer Service Specialist

    13 hours ago

    Vacaville, United States Mariani Packing Full time

    Job Opportunity: Customer Service SpecialistPay Rate – $23.47 – $28.16Come Join us and Grow with our Family! At Mariani, we believe that family comes first! We understand work is only part of what makes life rewarding. If you enjoy working in a flexible, respectful, collaborative environment where community members embrace change and seek continuous...

  • Instrumentation Technician

    4 weeks ago

    Vacaville, United States Consultant Specialists, Inc. (CSI) Full time

    ROCGJP00025233 Instrumentation Technician IIINote: 12 Month contractW2 Only - NO C2CLocation: Onsite in Vacaville, CASchedule: Candidates need to be open to all shifts (day or grave) 6am-6:30pm / 6pm-6:30am.Technical:Exhibit detail-oriented documentation skills to ensure Right-First-Time operations.Escalate process issues as necessary to ensure resolution of...

  • Project Administrator

    5 days ago

    Vacaville, United States Essel Environmental Full time

    ob Summary: We are seeking a detail-oriented and experienced Accounts Payable Specialist to join our finance team. The ideal candidate will be responsible for managing the accounts payable process, ensuring accurate and timely processing of vendor invoices and payments. Familiarity with Procore construction management software is highly...

  • Community Outreach Specialist

    2 weeks ago

    Vacaville, California, United States Choice Healthcare Services Full time

    Overview: Do you enjoy marketing outreach with organizing and attending outreach events and traveling locally for business-to-business outreach? If so, we are seeking a dynamic individual who loves to make an impact to join CHOICE Healthcare Services, where our mission is to provide everyone access to the healthcare they need. CHOICE is the largest provider...

  • Resource Specialist Teacher: RSP- Eugene Padan Elementary- Job No 25-1689

    3 weeks ago

    Vacaville, United States Vacaville Unified School District Full time

    Job DescriptionJob DescriptionAbout the EmployerVUSD works to achieve the mission of graduating all students by providing academic excellence and CHOICES that encourage unique and individualized learning experiences. We place precedence on imparting a sense of belonging and commitment to community. Fostering lifelong learning lays a foundation for character,...

  • Resource Specialist Teacher: RSP- Eugene Padan Elementary- Job No 25-1689

    2 weeks ago

    Vacaville, United States Vacaville Unified School District Full time

    Job DescriptionJob DescriptionAbout the EmployerVUSD works to achieve the mission of graduating all students by providing academic excellence and CHOICES that encourage unique and individualized learning experiences. We place precedence on imparting a sense of belonging and commitment to community. Fostering lifelong learning lays a foundation for character,...

  • Project Administrator

    1 week ago

    Vacaville, United States Essel Environmental Full time

    ob Summary:We are seeking a detail-oriented and experienced Accounts Payable Specialist to join our finance team. The ideal candidate will be responsible for managing the accounts payable process, ensuring accurate and timely processing of vendor invoices and payments. Familiarity with Procore construction management software is highly...