Robert Epps Email & Phone Number

Greenville, North Carolina, United States

• Lead the planning, scheduling, and communication of all required laboratory analytical testing to ensure the highest levels of efficiency and quality standards are met with occasional testing within the laboratory.• Initiate and perform investigations for out-of-specification and out of trend results as well as deviations from standard operating procedures. Ensure timely and comprehensive investigations in compliance with established internal procedures.• Ensure the quality of work, products, and services as a priority; comply with or exceed all regulatory, cGMP compliance standards, and data integrity requirements as well as ensure accuracy of analyses as it relates to right first time measures.• Follow all regulatory guidelines, cGMP guideline, Environmental Health and Safety regulations as required by the job function• Mentor and guides a team of 3-6 scientists and other laboratory personnel at various levels• Develop, evaluate, validate, verify or otherwise qualify compendial and non-compendial methods and procedures for excipients, actives, finished products and packaging components• Perform comprehensive and structured investigations for out of specification results or deviations utilizing company procedures and established root cause analysis techniques• Author and review analytical procedures, validation documents, portions of regulatory submissions for site non-commercial and commercial projects relating to QC• Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules • Project management and serve as Quality Control representative for internal and external clients, both commercial and non-commercial and, as required, CMOs• Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)

Greenville, North Carolina

• Follows all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function• Independently performs complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for known chemical entities and dosage forms; develops a series of tests to provide quality control for pharmaceutical raw materials, drug substances, or dosage forms; independently develops and/or evaluates methods of analysis for chemical entities and drug formulations• Proficient in the use of Empower (performs supervisory sign-off for electronic reports)• Develops basic methods of analysis when required• Designs method validation protocols and conduct validation experiments independently for pharmaceutical raw materials and dosage forms; interpret data, draws conclusions, and makes recommendations based on the data• May serve as a technical liaison between MCS and AIS for routine PQ’s and Troubleshooting• Reviews and witnesses laboratory notebooks and provides feedback as needed• Under general supervision authors analytical procedures and validation documents• Performs other duties related to the position when required by laboratory management• Suggests improvements of laboratory testing procedures, techniques and/or instrumentation• Assists laboratory personnel with the preparation and execution of laboratory investigations• Assists in laboratory personnel training when required

• Perform established methods independently.• Under general supervision, develop methods of analysis for known chemical entities and dosage forms using routine and simple techniques.• Maintain an accurate, well-kept laboratory notebook to document analysis.• Solve problems with a single method, instrument, or process.• Interpret data, draws conclusions, and makes recommendations based on the data.• Under general supervision, author analytical procedures and validation documents.

• Perform established methods under general supervision.• Interpret data, draws conclusions, and makes recommendations based on the data.• Serve as lab assistant to senior analyst.• Assists senior analyst in developing methods of analysis for known chemical entities and dosage forms using routine and simple techniques.• Maintain an accurate, well-kept laboratory notebook to document analysis.