Rick Augustine Email & Phone Number

Bothell, WA, US

Quality/Regulatory Compliance for Biopharma CDMO

• Review and Approval of Deviations and Quality Investigations: Aseptic Manufacturing, Aseptic Filling, Materials, Environmental Monitoring, Quality Control and Microbiology
• Created a training program for root cause analysis and quality investigation writing.

• Independent Consultant
• Supporting cGMP compliance and quality systems in the pharmaceutical industry
• Consulting services in the areas of Deviations/Investigations, Labeling, Auditing, Inspection Readiness, Gap Analysis, Validation and general Quality Systems needs.

• · Completed Remediation Efforts to resolve an FDA Warning Letter
• Gap Analysis of 18 Operations and 10 Quality SOPs and completed revision of 15 SOPs to comply with cGMP Regulations.
• Created a Stability Program for testing of 140 Active Pharmaceutical Ingredients.
• Trained Quality Control and Quality Assurance associates in GMP and GDP· Achieved a 30% increase in productivity by reorganizing a team of 27 associates in the Quality Assurance and Quality Control units at sites in.

Tongzhou District, Beijing, CN

Greenville, South Carolina, US

Provide leadership and direction for the Quality Assurance Department in the areas of Plant Quality Assurance, QA Batch Release, and Quality Investigations/CAPAs at three PAI manufacturing/packaging sites. Additionally, responsible for Quality Review/Approval of SOPs, Master Batch Records and protocols for PAI, CMOs and Suppliers.

Columbus, Ohio, US

Senior leadership position with responsibilities in the areas of Product Development, Pharmaceutical Stability, Quality, Regulatory, Validation and FDA Labeling Submissions. Provide strategic guidance as well as hands on management of the Stability Program, Labeling/Document Control, Quality Investigations, Product Recalls, Cleaning Validation.

Ingelheim Am Rhein, Rhineland-Palatinate, DE

Investigation of non-conformities encountered in manufacturing and packaging of solid-oral dosage and liquid pharmaceuticals, out-of-specification analytical results and product complaints, including written investigation reports and determination of product disposition.