Compliance Analyst

Job 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 internal 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 cGMPStandards. 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 resolutionJob RequirementsEducation and 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.Knowledge, Skills And Abilities 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 desirableWork Environment/Physical Demands/Safety Considerations 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.Pay Rate Range: $40-50/hr depending on experience