Quality and Compliance Specialist II/III

3 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.

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