Operational Compliance Specialist

** Operational Compliance Specialist - JLL (swing shift)
**** What this job involves
- ** 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.
* 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
* 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
* Previous experience working with regulatory agencies or conducting regulatory examinations
* Bilingual capabilities to support diverse client and tenant populations
* 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…