Independent contractor with over 13 years of Pharmaceutical and Medical Device Industry Quality Assurance and Quality Control experience, providing short-term compliance assistance for pharmaceutical, nutriceutical and medical device QA/QC programs. Also provide assistance with industry job searches and training resources.
Quality Assurance specialties in: GMP auditing (supplier or internal audits) Laboratory auditing (internal and vendor certification) Inspection/audit responses Corrective/preventive action plans Audit tracking systems Quality systems (investigations, complaints, change control) Documentation (batch records, procedures) Validation protocol review
Quality Control specialties in: Microbiology Sterile products Contamination control Laboratory investigations Contract lab audits Vendor certification Vaporized hydrogen peroxide barrier isolator systems Laboratory setup