JOHN I. RUSS

Lockport, New York *****

252-***-**** adkj2d@r.postjobfree.com www.LinkedIn.com/johnruss780 QUALITY ASSURANCE PROFESSIONAL

Accomplished and motivated Pharmaceutical Quality Control Professional with extensive expertise in Quality Control laboratory and Quality Assurance functions. Proven ability managing quality compliance systems. Adept at overseeing all site annual product reviews, for an extensive number of products in varying dosages. Team oriented with a focus on ensuring product integrity, regulatory compliance, and enhance corporate growth.

CORE COMPETENCIES

Quality Control Quality Assurance Systems Data Processing Auditing Laboratory Management Safety

Change Control Collaboration Annual Product Reviews Word Processing Excel /Minitab EXPERIENCE

Sandoz/Novartis Pharmaceuticals, Wilson, NC 2/2008 – 1/2021 Quality Compliance/Systems, 9/2010 - 2021

Managed site compliance for all Annual Product Review (APR) reports; including composition and review of product reports; collaborating with various departments for associated data. Chaired weekly Change Control meeting, as a Coordinator for the site, and assigned Stakeholders using Trackwise Software.

• Performed all site stability adverse trending of product shelf-life, using Minitab Software. Data was critical in the establishment of product Bulk Release Limits.

• Participated as a lead Auditor in the internal audit program, providing feedback and suggestions to drive process improvement and compliance continuity.

• Provided Site Quality Assurance approval of product labels and packaging safety inserts, ensuring the correct use of the product to promote consumer safety.

• Managed Quality Control Release Limit documents and associated archiving of obsoleted forms. Senior Quality Engineer, 1/2009-9/2010

Reviewed and approved laboratory investigations on finish products, stability, raw materials, and ARD analyses. Collaborated with the investigators as to additional items to consider to address the event, within the timelines allowed.

• Review and Approve Laboratory Investigations, Deviations, and CAPAs, as needed, to evaluate for complete detailed root cause analysis. Promote process enhancement by ensuring the identified corrective actions address the root cause, following up with timely Effectiveness Checks.

• Review and approve QC Change Control and SOP/Method revisions, against supporting documentation, maintaining original process/system validation.

• Conduct Customer Complaint Investigations and write supporting report, detailing the root cause and corrective actions. Perform trend analyses for similar events. John I. Russ adkj2d@r.postjobfree.com Page Two

Senior Quality Control Chemist, 2/2008-1/2009

Performed Laboratory Investigations on Finish Products, Stability, Raw Materials and ARD samples.

• Train and coach laboratory chemists on performing Laboratory Out-of-Specification investigations Root-cause analysis, and creation of corrective actions, using Trackwise.

• Implemented deviation/investigation program for the Wilson site Quality Control area. Microbac (Southern Testing) Laboratories, Wilson, NC 6/2006 – 2/2008 Quality Assurance Officer

Performed Departmental Audits, host Client Audits, as needed. Address the areas within Microbac Labs to ensure contract testing is in compliance with the vendor needs detailed in the Quality Agreements.

• Manage QA systems for compliance with current SOPs, primarily focusing on performing department periodic audits.

• Initiate Change Controls, Deviations, and CAPA as needed to Quality systems, as specified within the individual Client Quality Agreements.

• Perform USP Compendial Raw Material Pharmaceutical analysis as requested, both wet and instrumental analysis.

ADDITIONAL RELEVANT EXPERIENCE

Contract Pharmaceuticals Limited Niagara, Buffalo, New York QC Group Leader/Supervisor

Diosynth Biotechnology (Akzo-Nobel), Morrisville, NC Senior Quality Control Associate

Bristol-Products Division of Bristol-Myers Squibb, Morrisville, NC Quality Control Chemist

EDUCATION

Canisius College, Buffalo, New York

Bachelor of Science, Technical and Liberal Studies, Chemistry Concentration Erie Community College, Amherst, New York

Associate in Applied Science, Chemical Technology

CERTIFICATION

North Carolina State University, Raleigh, North Carolina Manager of Environmental, Safety and Health Certificate