X2 logics · 20 hours ago
Documentation Specialist
Hauppauge, NY
Full-time
Onsite
Mid, Senior Level
2+ years expX2 logics is seeking a detail-oriented contractor to support Document Specialist/Operations Investigator in a pharmaceutical environment. The role involves investigating manufacturing and packaging deviations, preparing reports, and ensuring compliance with cGMP standards.
Information Services
Hiring Manager
shahrukh Mushtaq
Responsibilities
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)
Qualification
Required
A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required
2-5+ years' experience
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)
Company
X2 logics
At X2logics, we are focused on building custom solutions to meet your business? needs.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase