Operational Compliance Specialist

About This Role

This role involves ensuring operational compliance within GMP buildings at Genentech Oceanside, CA, by implementing compliance programs, conducting audits, and investigating issues. The specialist plays a crucial role in mitigating risks and maintaining ethical and legal operational standards.

Responsibilities

• Develop and implement compliance policies and procedures to ensure adherence to regulations
• Conduct audits and assessments to identify compliance issues and risks
• Collaborate with internal teams to address compliance concerns and implement corrective actions
• Keep up-to-date with regulatory changes and ensure company-wide compliance
• Provide compliance training and guidance to employees
• Maintain qualifications as a Qualified OJT Trainer
• Ensure front line employees are current on their training by running periodic reports for all learning systems
• Investigate compliance violations and assist supervisors with appropriate disciplinary actions when necessary
• Maintain accurate records and documentation related to compliance activities
• Participate in industry forums and stay informed about best practices in compliance
• Provide timely review of all documentation per area relevant SOP’s
• Champion continuous improvement, including identifying and implementing projects
• Back up GMP supervisor to ensure coverage in absence of area GMP supervisor if a need arises
• Support GMP pest control program, including performing audits, generating quarterly pest control reports, and ensuring an effective and compliant pest control program

Requirements

• 2+ years of work experience in compliance, risk management, following regulatory bodies or similar within pharmaceutical, bio-technology, cosmetics or manufacturing
• Familiarity with cGMPs and FDA guidelines
• Strong written and verbal communication skills

Qualifications

• 2+ years of work experience in compliance, risk management, following regulatory bodies or similar within pharmaceutical, bio-technology, cosmetics or manufacturing

Nice to Have

• Previous experience working with regulatory agencies or conducting regulatory examinations
• Bilingual capabilities