Biopharma QA Auditor | Compliance SME (Hybrid)

Avid Bioservices; Tustin (CA); Hybrid; USD 103,200 - 129,000; Full time

Job summary

Avid Bioservices in United States, California, is seeking an individual contributor to oversee audits, data reviews, and regulatory compliance activities integral to cGMP practices. You will prepare audit reports, coordinate corrective actions, and support supplier quality with metrics and SOP updates.

The role emphasizes ongoing QA expertise, SOP creation, and collaboration with cross‑functional teams to uphold regulatory standards and patient safety.

Qualifications

• 5+ years in pharmaceutical/biopharmaceutical or related industry preferred.
• Sound knowledge of cGMPs or equivalent regulations.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to allocate resources and manage priorities.
• Audit skill and/or certification preferred.

Responsibilities

• Perform independent internal and external audits for adherence to cGMPs and other relevant Federal, foreign and corporate regulations and policies.
• Follow up on audit response and corrective actions.
• Review vendor data, records and documents to assess appropriateness of materials and services to be used in a cGMP environment.
• Process new vendor requests for the organization and independently perform qualification activities to provide recommendations to management.
• Serve as the Quality Compliance representative on cross‑functional teams.
• Identify, design, and implement process and system improvements.
• Evaluate regulatory requirement changes, impact to company’s operations and make recommendations to management.
• Support client audit and regulatory inspection (FDA and Foreign) activities.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality Compliance processes and issues.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• May conduct investigations related to non‑compliance matters.
• Follow company policies and procedures.
• Establish work priorities to meet targets and timelines.
• Review and approve quality management records.
• Participate in Supplier discrepancy investigations. Ensure discrepancies are thoroughly identified, defined and properly assessed.
• Participate in company audit readiness activities by identifying any systematic compliance gaps and subsequently working inter‑departmentally to mitigate the risks of the gaps.
• Interact with interdepartmental contacts on Supplier discrepancy assessment, resolution, and quality approval.
• Provide guidance to internal and external customers on best practices for maintaining a quality program.
• Ensure that the proper policies and procedures are in place.
• Identify, design, and implement process improvements.
• Provide input into the design and presentation of departmental performance metrics.
• Occasional overnight travel by land and/or air may be required to conduct audits, attend seminars or conferences.
• Perform other duties as assigned.

Skills

Auditing

Quality compliance

cGMP knowledge

Documentation review

Regulatory awareness

Education

B.A./B.S. in Life Science

Job description

Avid Bioservices in United States, California, is seeking an individual contributor to oversee audits, data reviews, and regulatory compliance activities integral to cGMP practices. You will prepare audit reports, coordinate corrective actions, and support supplier quality with metrics and SOP updates.

The role emphasizes ongoing QA expertise, SOP creation, and collaboration with cross‑functional teams to uphold regulatory standards and patient safety.