QA Associate Auditor

QA Associate

Essential Skills

• Skilled auditor with 4 years of experience in performing investigative audits.
• Experience in quality assurance in a highly regulated manufacturing environment.
• Familiarity with EQMS systems.
• Competence with Microsoft Excel, PowerPoint, and Word.
• Experience with Microsoft Teams, SharePoint, and Zoom.
• ASQ Certified Auditor or equivalent level of experience/knowledge.
• Knowledge of the industry including transportation, warehouse, and supply chain.
• Pharma, Biotech Quality systems experience.
• 5+ years of relevant experience and a BS/BA degree, preferably in a scientific field.
• Thorough knowledge of compliance requirements and understanding of current global and regional compliance trends.
• Knowledge of domestic and international GDP regulations including 21 CFR Parts 11, 203, 205, 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; Health Canada, EU GDP; ICH, ISO, PIC/S and USP/NF, EP, and JP compendial standards and principles.

Additional Skills & Qualifications

• Auditor certificate such as ASQ (American Society for Quality) or equivalent.
• Biopharmaceutical or Pharmaceutical experience preferred.

Job Description

Primarily conduct global vendor audits for GDP suppliers. Support and/or conduct audits of providers of warehouse/distribution in support of clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned. Manage all aspects of the audit lifecycle, including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing. Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team. Work directly with cross-functional departments to gather key information and feedback prior to conducting vendor audits to ensure effectiveness. Align, strategize, and collaborate with the Global Product Distribution & Affiliates to address compliance risks and escalate issues to appropriate levels of management for resolution. Promote awareness across the biologics commercial and clinical manufacturing platforms of current regulatory agency requirements and trends, and develop and report on the trends identified to better focus the scope of audits. Drive consistency with audit report observation writing, classification, status, and overall risk. Conduct due diligence assessments as part of global expansion as required.

Responsibilities

• Conduct global vendor audits for GDP suppliers.
• Support and/or conduct audits of warehouse/distribution providers.
• Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
• Ensure the audit agenda is risk-based with appropriate subject matter experts.
• Gather key information and feedback from cross-functional departments prior to audits.
• Align, strategize, and collaborate with the Global Product Distribution & Affiliates to address compliance risks.
• Promote awareness of regulatory requirements and trends across biologics commercial and clinical manufacturing platforms.
• Develop and report on identified trends to better focus audit scope.
• Drive consistency with audit report observation writing, classification, status, and overall risk.
• Conduct due diligence assessments as part of global expansion.

Work Environment

Remote work with the requirement to be in the Pacific Time Zone. Opportunity to gain pharma industry supply chain auditing experience with the possibility of extension.

Pay and Benefits

The pay range for this position is $60.00 - $63.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Foster City,CA.

Application Deadline

This position is anticipated to close on Mar 6, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.