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As an Operational Compliance Specialist, the incumbent in this role is responsible for safe, efficient, innovative, compliant and cost-effective operation within all GMP buildings while maintaining full compliance with current Good Manufacturing Practices, corporate principles, quality policies and standards at Genentech Oceanside, CA campus. The job involves implementing compliance programs, conducting audits, providing training, ensuring training compliance and investigating any compliance issues that arise. The operational compliance specialist plays a crucial role in mitigating risks and ensuring that the staff operates ethically and within legal boundaries. Strong attention to detail, analytical skills, and a solid understanding of area relevant SOP’s are critical for success in this role. The successful candidate for this role must understand cGMPs and should be able to assist with investigations, CAPAs, risk assessments, audits, standard operating procedures (SOP) revisions, change control documentation and training materials for use by the JLL teams and sub-contractors in the performance of their work. The incumbent is expected to ensure that all applicable procedures are followed, and that the work performed by the front line employees is documented and recorded in accordance with area relevant SOP’s and forms. Successful candidate will support sustainment of the GMP program for with respect to the scope of work JLL is responsible for and evolve the program over time. Candidate must have a strong commitment to quality assurance, must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision. Candidate must have good oral and written communication skills including the ability to communicate to all levels of management and interface with a diverse customer base including technical and non-technical personnel. This is a full time, on-site, exempt, bonus eligible position.
Job Responsibility:
Developing and implementing compliance policies and procedures to ensure adherence to regulations
Conducting audits and assessments to identify compliance issues and risks
Collaborating with internal teams to address compliance concerns and implement corrective actions
Keeping up-to-date with regulatory changes and ensuring company-wide compliance
Providing compliance training and guidance to employees
Maintain qualifications as a Qualified OJT Trainer
Ensuring front line employees are current on their training by running periodic reports for all learning systems
Investigating compliance violations and assisting supervisors with appropriate disciplinary actions when necessary
Maintaining accurate records and documentation related to compliance activities
Participating in industry forums and staying informed about best practices in compliance
Providing timely review of all documentation per area relevant SOP’s
Continuous improvement champion 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 but not limited to performing audits, generating quarterly pest control reports, and ensuring an effective and compliant pest control program
Performs other related duties as assigned
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 with ability to explain complex regulations to diverse audiences
On-site presence for this job function is a must
Troubleshooting/on-call support is required outside of normal working hours
At times this role requires access to a clean room environment which requires company supplied gowning to cover exposed skin and hair in accordance with cGMP guidelines
Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines
Candidates must be authorized to work in the United States without sponsorship
Nice to have:
Previous experience working with regulatory agencies or conducting regulatory examinations
Bilingual capabilities to support diverse client and tenant populations