Compliance Analyst

In this exciting role at Oceanside, you will be responsible for coordinating and issue resolution across Biochemical Manufacturing Operations, other groups and/or projects. Maintain quality system records in compliance with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Perform critical, technical and operational review and approval of documentation related to the design, validation, operation and maintenance of biochemical manufacturing processes, equipment and facilities (including engineering changes, document changes, discrepant event assessments and summaries, validation documentation, etc.). Work with MSAT, Compliance and Quality Assurance to resolve quality issues. Manage, lead, and implement operational excellence efforts to solve complex problems while maintaining required levels of safety, quality, regulatory compliance, and production. Incumbents in the Manufacturing technical specialist role, as all other employees, in GMP Services, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities. Enable Oceanside product(s) in consistently meeting our customer and regulatory requirements by developing, improving, and/or implementing processes, concepts and strategies. 

The Opportunity

•  Manage and resolve technical and compliance issues with Quality, Technology, Maintenance, Facilities, Calibration & EH&S. 

• Solve a wide range of difficult issues that impact multiple functions following cGMP regulations and Genentech standards by applying advanced theory, technical principals and expert judgment. 

• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership. 

• Lead and and/or facilitate Root Cause Analysis sessions for more complex issues and serve as a coach and process owner for DMS Event Observer/DO Community within their function on best practices 

• Be able to act as SME to regulatory agencies 

• Implement and follow through on corrective and preventative actions (CAPA) in accordance with timelines.

Who you are

• BS/BA in Life Sciences/Engineering preferred, and at least 5 years’ experience in the pharmaceutical, biopharmaceutical industry or a combination of education and experience.

• Ability to make sound decisions about scheduling, allocation of resources and managing of priorities. 

Preferred

• Strong oral and written communication skills. 

• Ability to make sound decisions with minimal supervision. 

• Possess thorough knowledge and understanding of cGMPs and familiarity with FDA, ICH and European guidelines. 

• Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

• Experience in technical writing, such as, creation and revision of Standard Operating Procedures or other technical reports/evaluations is desirable 

Work Environment/Physical Demands/Safety Considerations

•  Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. 

• Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a load environment. 

• May work with hazardous materials.

Relocation benefits are available for this posting

The expected salary range for this position based on the primary location of Oceanside, CA is $83,000-154,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits 

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.