Darren Fields Email & Phone Number

St. Louis, Mo, Us

Mentor, Oh, Us

St Louis, Us

– Authored and revised Standard Operating Procedures through Document Change Control– Issued Batch Records and Product Labels for API manufacturing– Reviewed analytical data and Batch Records for accuracy and completeness– Approved and Released Finished Products– Authored Process Validation and Qualification Protocols– Communicated with clients regarding Quality Assurance matters– Functioned as lead during FDA Inspection

Mumbai, In

– Worked to complete open Corrective and Preventive Actions (CAPAs)– Revised Standard Operating Procedures through Document Change Control – Conducted root cause investigations for Non-Conformance Reports

Wilmington, Nc, Us

– Served as the primary point of contact for the client’s product development– Coordinated project activities to ensure activities were completed on time and on budget– Managed scope of projects and communicated updates to the client– Collaborated with internal and external functional departments and lead technical teams– Managed multiple projects concurrently

Saint Louis, Mo, Us

-Customer Complaint Investigation; Corrective Action-Responding to technical product related customer inquiries and audits-Batch record review/approval-Batch Record Issuance -Label Issuance & Review-Authoring/Revising Standard Operating Procedures (SOP)-Mock Recall-Maintaining Halal and Kosher Certifications

Dublin, Oh, Us

• Demonstrated expert understanding of all levels of the production job family and applied thorough knowledge of jobs outside area of responsibility• Provided technical guidance and training to others• Worked on complex problems that required independent action• Employed a high degree of initiative to resolve mechanical or production issues

Dublin, Oh, Us

• Coordinated and supervised the daily activities of business support, technical, and production staff• Set priorities for the team by establishing reasonable short and long term goals to ensure task completion• Utilized in depth knowledge of work processes and tools to solve standard and non-standard problems within laboratory• Provided direction in discussing and creating development plans for staff• Built customer relationships, interpreted their needs, and assessed their business requirements• Leveraged customer knowledge to develop alternative solutions and shared key learning with others

Dublin, Oh, Us

• Responsible for ensuring cGMP training and compliance• Managed the quality control and assurance programs• Identified quality issues and directed corrective measures for compliance with agency regulations and company procedures and policies• Performed root cause investigations, completed non-conformance reports, and provided correction actions for any out of specification or non-conforming issues• Ensured products met all customer safety standards

Dublin, Oh, Us

• Executed the complete production of Fludeoxyglucose • Maintained inventory control including all raw material ordering • Worked closely with Supervisor to ensure that the manufacturing site was consistently producing Fludeoxyglucose according to FDA operational expectations• Communicated with pharmacists and pharmacy technicians on a daily basis to ensure that the needs of the customer were met with satisfaction

• Managed production activities and associated personnel in the production of Fludeoxyglucose• Assisted in employee development and training• Placed purchase orders for raw materials and managed inventory control• Collaborated with Pharmacy manager to develop an effective and efficient production schedule to meet customer needs and delivery times

• Acquired working knowledge of FDA and USP regulations • Performed quality control tests such on radiopharmaceutical• Prepared equipment and compounded reagents necessary for radiopharmaceutical synthesis

Bachelor Of Science (B.S.), Biology/Biological Sciences, General

Associate Of Arts (A.A.), Pre-Medicine/Pre-Medical Studies