GMP/ FDA Compliance Analyst

Please note that this is a 6 months contract position. Two Shifts Available:NIGHTS-6PM to 6:30AMDAYS- 6AM to 6:30PMPosition Summary: As the Analyst, you are a technical expert supporting and overseeing the manufacture of biological products. You will provide technical expertise to ensure that production activities and the sampling and testing of materials and products are completed in compliance with all applicable procedures and regulations. You will monitor key process parameters. You will support troubleshooting efforts, document manufacturing problems as required, provide technical support and will identify and support implementation of process improvements. Key Responsibilities:• Provide primary (on floor) production oversight to ensure execution according to standard operating procedures.• Observe processing activities; identify and document processing issues.• Recommend corrective/preventative measures aimed at improving compliance and reducing repeat occurrences.• Identify process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.• Review and monitor process trends and process data on trained procedures.• Review documentation in SOP’s, logbooks and other GMP documents.• Demonstrate expertise in a number of the following areas: cGMPs, FDA regulations, Cell culture, chromatographic purification, ultrafiltration, diafiltration, viral inactivation, filter integrity testing, or pharmaceutical water systems and utilities.• Provide documentation support for SOP/ Batch Record revisions, identify and communicate necessary document changes to ensure timely revision to all SOP and batch records and review and approve SOP and Batch record revisions. Minimum Qualifications:• Associate’s degree / Bachelor’s preferred, focused degree in Technical area is highly desirable• At least 2-5+ years of related experience in a cGMP manufacturing environment, biopharmaceutical, or pharmaceutical industry• Ability to interpret and carry out a variety of technical or other instructions• Ability to apply principles of logic or scientific thinking to define and deal with intellectual and practical problems, involving abstract and concrete variables in standardized situations, and collect data, establish facts, and draw valid conclusions• Ability to make innovation part of the site agenda and be an active driver of innovation, thinking outside of the box and challenging others to do the same Preferred Skills/Experience:• Providing training and/or mentoring to others• Ensuring compliance including adherence to local, state, and federal regulations and guidelines (EPA, OSHA, cGMP, FDA).• Expertise in one or more of the following areas highly desirable: Cell culture, chromatographic purification, ultrafiltration, diafiltration, filter integrity testing, or pharmaceutical water systems and utilitiesApplicants must provide their phone number. Reference job number A908.