Documentation Specialist

Seeking a detail-oriented contractor to support Document Specialist/Operations Investigator in a pharmaceutical environment

• Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implementation of Corrective and Preventative Actions (CAPAs) to prevent recurrence.
• Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event.
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non-conformances and communicating findings and recommendations at group meetings.
• Ability to conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions.
• Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations.
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures.
• Monitoring production processes to acquire vital data in support of investigations and track the efficiency of changes.
• Gathering, trending, and analyzing process-related data to drive consistency and timeliness.
• Training new employees in investigative processes and techniques and documenting all training.
• Coordinating and/or leading cross-functional meetings with multiple departments.
• Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same.
• Evaluating, developing, and qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols.
• Risk assessment and risk mitigation by performing FMECA (Failure modes, effects, and criticality analysis)

• A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required.