Compliance Analyst

Position Title: Compliance Analyst

Work Location: Oceanside, CA, 92056

Assignment Duration: 6 Months

Work Arrangement: Onsite

Position Summary:

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 The Organization standards by applying advanced theory, technical principals and expert judgment.

Background & Context:

Role focuses on deviation management, discrepancy ownership, and ensuring compliance in biopharmaceutical manufacturing clean rooms.

Key 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 principals 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 and/or facilitate Root Cause Analysis sessions for more complex issues.

* Act as the Discrepancy Owner Lead by.

* Execute 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 tracking actions related to deviation resolution.

Qualification & Experience:

* 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.

* 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.

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

* Have proficiency with the following software: 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.

Working Conditions & Physical Demands (If Applicable):

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

* Some 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.