Drug Safety/Medical Information Specialist jobs in Lexington, KY

Responsible for providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing and testing. Also responsible for review of controlled cGMP documentation and manufacturing records including any deviations or OOS that may have occurred during lot production as well as investigations. Participates during the release of raw materials, intermediates and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.

Essential Duties:

• Supports the development and maintenance of Quality Systems as appropriate.
• Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
• Advises senior management on findings and recommendations related to internal and external auditing.
• Manages the CAPA and Change Control Systems.
• Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents.
• Develops and maintains metrics and trending reports for Compliance-related activities.
• Reviews and approves product complaint investigations and assists with investigations.
• Performs activities associated with various one-time or on-going projects (from participation level to project manager).
• Collaborates with departments and external suppliers regarding quality concerns.
• Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
• Supports regulatory inspections and customer audits.
• Assists Manager with daily and project activities as needed.
• Other duties as assigned.

Qualifications: 

• Bachelor degree in a scientific discipline
• At least 7 years Pharmaceutical/Medical Device cGMP quality experience
• Knowledge of HPLC principles and ability to review data for accuracy and completeness
• Ability to assess problems, to identify solutions, to plan and implement necessary changes
• Experience in quality systems auditing (internal and/or external) preferred
• Experience in manufacturing aseptically filled, sterile products preferred
• Advanced knowledge of cGMP regulations and validation principles
• Ability to work well in a team oriented environment
• Well-developed communication and technical writing skills
• Qualified to work with controlled substances