Senior auditor Jobs in Anaheim, CA

Senior Auditor and Compliance Specialist - cGMP

• Must be local to the Los Angeles area
• This is a Pharmaceutical Manufacturing role

The Senior Auditor and Compliance Specialist is responsible for maintaining the Quality Systems and ensuring compliance with current Good Manufacturing Practices (cGMPs) across multiple disciplines, including Pharmaceuticals, Nutritional Supplements, Food, Cosmetics, and Medical Devices (21 CFR Part 111, Part 210 / 211, Part 802).

The primary responsibilities of this role include :

Managing and coordinating PureTek's training and Audit program.

Writing and updating Standard Operating Procedures (SOPs) / manuals and regulatory guidelines.

Preparing management reports upon request.

This position requires independent decision-making, applying industry best practices, cGMPs, SOPs, and regulatory requirements. Additionally, the Senior Auditor will assist in developing and maintaining company-wide safety programs, the HACCP program, and organic certification compliance.

Maintain and manage the PureTek training program :

Publish the annual training calendar and distribute it to department managers.

Coordinate training sessions across all departments.

Maintain the training matrix and track training compliance for all departments.

Audit Planning and Execution :

Develop and execute risk-based audit plans for internal processes and external suppliers.

Conduct audits in accordance with established procedures, ensuring objectivity and independence.

Evaluate the effectiveness of quality systems and identify areas for improvement.

Document audit findings clearly and concisely.

Audit Reporting :

Prepare comprehensive audit reports detailing observations, deviations, and recommended corrective actions.

Present audit findings to relevant stakeholders, including management and auditees.

Track and verify the implementation of corrective and preventive actions (CAPAs).

Ensure all corrective and preventive actions are documented and implemented.

Ensure compliance with Company SOPs, cGMPs, and regulatory guidelines.

Maintain Quality Systems logs and track timely completion of tasks.

Process Questionable Material Reports (QMR), Material Destruction Records (MDR), Deviations, and Reprocessing Orders (RO) as needed.

Collect and review monthly reports from the Quality Unit.

Manage the complaints program, including documentation and responses.

Update SOPs and assist with other QA-related documents.

Maintain QA records and documentation.

Audit fire extinguishers, eye wash stations, and emergency shower inspection reports.

Conduct facility audits to ensure compliance with state and federal safety regulations.

Adhere to company policies and procedures, setting a positive example for the organization.

Establish priorities to ensure timely job completion.

Demonstrate excellent interpersonal skills and professionalism with company management, staff, vendors, and regulatory agencies.

Perform any additional tasks assigned by the supervisor / management.

Qualifications

To perform this job successfully, an individual must be able to execute each essential responsibility effectively, using the skills and abilities outlined below. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Ability to handle confidential and sensitive matters with discretion.

Knowledge of drug cGMPs, SOPs, and FDA regulatory guidelines.

Understanding of QA industry best practices.

Education & Experience

Bachelors degree in science (Chemistry, Pharmacy, or Biology) or equivalent work experience.

Minimum of 5 years of experience in quality assurance or auditing roles within the pharmaceutical industry, with a focus on contract manufacturing.

Proven track record of conducting successful audits and driving quality improvements.

Strong knowledge of cGMP regulations (21 CFR Part 210 / 211) and other relevant industry standards.

Certifications :

ASQ Certified Quality Auditor (CQA) or equivalent certification preferred.

Technical Skills

Proficiency in Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.

Ability to quickly learn and adapt to new software programs as needed.

Seniority level Mid-Senior level

Employment type Full-time

Job function Accounting / Auditing and Finance

Industries Pharmaceutical Manufacturing

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