Compliance Analyst

Job Title: Compliance Analyst

Location: Oceanside CA 92056

Type: Contract

Compensation: $45.00 - $50.57/hr

Work Model: Onsite

Responsibilities

• 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 principles, and expert judgment.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership.
• Provide technical assessments for controlled document changes. Review and approve Change Requests. Participate with discrepancy investigations as well as interact with interdepartmental contacts ensuring discrepancy identification, definition, assessment, and resolution.
• Be able to act as SME to regulatory agencies.
• Identify the technical, procedural, and equipment issues that may compromise production and compliance, working closely with cross-functional groups to identify and implement solutions.
• Implement and follow through on corrective and preventative actions (CAPA) in accordance with timelines.
• Ensure that all operations are performed with 100% compliance to documentation cGMP Standards.
• Ensure maintenance of a safe manufacturing work environment that complies with company and state regulations.
• Evaluate data, resolve complex problems, and provide input to investigations to Out of Action Limits related to manufacturing clean rooms.
• Manage project teams to troubleshoot and proactively minimize potential for microbial contamination in the manufacturing clean rooms.
• Oversee the manufacturing input for the prompt closure of Adverse Trends through corrective action implementation.
• Lead and/or facilitate Root Cause Analysis sessions for more complex issues.
• Act as the Discrepancy Owner Lead by executing discrepancy ownership tasks while maintaining compliance with GSP009, cGMPs, and supporting department/site goals.
• Identify and assign initial assessments, attend triage, and review assessments.
• Summarize deviations and route to QA for closure to support site cycle time goal.
• Identify, create, and track to closure actions related to deviation resolution.

• 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 priorities.
• Direct experience with mammalian cell culture and/or purification of biopharmaceutical products.
• Strong oral and written communication skills.
• Ability to make sound decisions with minimal supervision.
• Thorough knowledge and understanding of cGMPs and familiarity with FDA, ICH, and European guidelines.
• Proficiency with Microsoft Word, Excel, and Project.
• 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific