Document Control Specialist

Coordinated the submission, approval, distribution, and archival of all manufacturing, packaging, and quality assurance documentation. 

Reviewed and approved manufacturing and packaging batch records for adherence to cGMP. 

Assisted Regulatory Affairs in the preparation of NDA and ANDA filings and supported FDA inspections.

Document Control Administrator / Complaints Invest

Created and managed controlled documents and quality records. 

Fully investigated customer complaints, ensuring trends were monitored and reported to appropriate personnel. 

Maintained documentation for compliance with FDA regulations and company policies. 

Assisted in many successful audits. 

Trained in Corrective / Preventative Actions 

Initial training in Risk Management

Document Control Administrator

Created and revised controlled documents (SOPs, policies, work instructions) and maintained the EDMS process. 

Reviewed and performed quality control of approved documents for accurate format, signatures, and Good Documentation Practices (GDP) prior to final release. 

Managed the document/drawing change control processes to ensure standardization and accuracy. 

Responsible for the storage and retrieval of quality records generated following the PFG Binder procedure. 

Trained as an SAP Quality Manag... Read More