Nicholas Scott
GMP Officer
Walden,NY
Summary
A versatile GMP Officer with 18 years of experience in the pharmaceutical industry ranging from aseptic manufacturing, solid dose manufacturing, gene therapies and Bio-Pharma. Responsible for closing CAPA's and investigations in systems such as TrackWise. Reviews and approves manufacturing and QC related documents for batch record disposition. Participates in overseeing various quality activities on the manufacturing floor.
Advanced knowledge of MES, TrackWise, LIMS, SAP, industry specific SOP's, PBR, MBR, and Excel.
Overview
22
22
years of professional experience
13
13
years of post-secondary education
Work History
QA Manager, ADC Operations
Pfizer
04.2023 - Current
- Increased customer satisfaction with products by ensuring consistent quality across all platforms and devices.
- Conducted root cause analysis on recurring defects, implementing corrective measures to prevent future occurrences.
- Mentored junior team members, providing guidance and support to help them excel in their roles and contribute effectively to the organization.
- Enhanced product quality by implementing rigorous testing procedures and protocols.
- Leading the "Aseptic Coaching" program.
QA Manager Shop Floor
Sanofi Pasteur
08.2021 - 04.2023
- Perform real time reviews of manufacturing batch records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations.
- Perform consistent review of logbooks on shop floor (Manufacturing, QC, Engineering and Facilities).
- Perform weekly GEMBA walk throughs in manufacturing, QC, Engineering.
- Quality review/release of manufacturing areas.
- QA oversight of deviations, CAPAs, ERs and change controls.
- Manage CAPA creations, implementation reviews and ERs.
- First responder to address any non-routine events on shop floor.
- Assist in audit – QA representation for tours as needed.
- Created and delivered presentations to address quality gaps for internal and external audits.
<p>GMP Officer</p>
Novartis Pharmaceuticals
10.2018 - 08.2021
- Provides oversight to Bio-Pharmaceutical operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
- Reviews and audits production batch records to ensure adherence to Novartis policies, SOP's, and cGMP requirements.
- Oversight of aseptic operations including but not limited to ViMOS, APV program, EM monitoring program, etc.
- Interface closely with Production Unit to assist with batch record review, release and compliance issues.
- Triaging of issues, initiate deviation reports in Trackwise and partner with Production Unit and other areas for issue resolution.
- Actively participates in process improvement initiatives aiming for RFT on documentation and deviation reduction.
- Ensures documentation is compliant with existing procedures.
- Reviews and approves deviations, investigations and CAPA plan establishment in accordance with applicable SOP's.
- Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings.
- Implements and ensures adherence of appropriate regulations and Novartis quality standards.
- Writes, reviews and approves Standard Operating Procedures as needed.
- Provides documentation for self-inspections and external audits.
- Interacts with FDA, partner sites and supplier auditors/inspectors as needed.
- Promotes and supports a Quality Culture and ensures a safe working environment.
- Represents QA onsite at cross-functional meetings. Provides QA input and disseminates information back to QA as needed.
- Completes job-related training as required.
- Disposition of incoming raw materials for use in production. Disposition and release of final product for market release.
- Strong knowledge and application of the CFR's and cGMP's.
- Reviews on-site systems and paper and electronic batch records.
<p>Quality Assurance Inspector</p> <p></p>
Halo Pharmaceuticals
09.2016 - 09.2018
- Inspect, sample, test, and disposition all incoming raw materials and packaging components following SOP’s utilizing various measuring devices such as scales, micrometers and height gauges.
- Preparation of samples for chemical and microbiological analysis for the QC lab.
- Maintain detailed records of inspections and testing for sampling activities via Microsoft Excel.
- Assign and verify the expiration date and retest date for all cGMP raw materials through vendor COA.
- Collect packaged product samples for annual stability testing.
- Perform room, equipment and packaging line clearance prior to each stage of manufacturing following SOP’s.
- Conduct in-process testing per manufacturing and packaging batch record instructions.
- Prepare controlled, uncontrolled and packaged finished product samples for QC lab and QA retains.
- Preliminary inspection, sampling and documenting of labels, components and outserts for either quarantine or release.
- Issue label components and outserts according to packaging order. Daily auditing of label room.
- Complete QA final labeled product inspection report for release.
- Train and mentor junior employees, including providing insight and education on processes and procedures.
- Proficient in the use of global systems and applications (e.g. Trackwise, SAP).
- Responsible for initiating and authoring investigations in response to deviations associated with raw materials, product, labs and materials. Initiate CAPA after investigation closes if needed.
- Review and correct controlled documents including production batch records and SOP’s.
- Gown certified in class 100 areas, perform line clearance inside clean room before start of production.
<p>Lead Manufacturing Operator</p> <p></p>
Novartis Pharmaceuticals
11.2005 - 08.2016
- Operate, disassemble/assemble, monitor, and maintain various manufacturing equipment throughout the manufacturing and packaging process of controlled/non-controlled substances, e.g., Fluid bed drying, Powrex (high shear granulation), Readco, Gral, Frewitt Milling, Fitzmill, Comil.
- Develop new sampling protocols and standard operating procedures.
- Resolve equipment failures and ensure all products conform to specifications.
- Review executed cGMP records and product batch records to ensure compliance and product quality.
- Conduct OTJ training/mentoring for team members on equipment, documentation, and procedures.
- Manage operations on the shop floor, e.g., allocated team members to top priority rooms based on business needs.
- Drove continuous improvements utilizing Lean manufacturing by analyzing KPI’s and developing a path to increase efficiency.
- Assist in development/sustainability of 5S manufacturing inclusive of rezoning production areas and material flow.
- Perform Microbial and Analytical sampling for routine monitoring and key validation projects.
- Identify deviations and triage the event to collect pertinent data for investigation.
<p>Lead Aseptic Operator</p>
Wyeth Pharmaceuticals
02.2002 - 11.2005
- Gown Certified in Class 100 areas. Performed daily tasks with Aseptic Technique and clean room behavior.
- Operate Component preparation, filling, capping, inspection of biological material, and packaging equipment. Participate in medial fill runs to validate implemented procedures.
Education
Rockland Community College, Liberal Arts, AA
09.2005 - 05.2010
SUNY Empire State College, Business Administration, BA
09.2014 - 12.2022
Timeline
QA Manager, ADC Operations
Pfizer
04.2023 - Current
QA Manager Shop Floor
Sanofi Pasteur
08.2021 - 04.2023
<p>GMP Officer</p>
Novartis Pharmaceuticals
10.2018 - 08.2021
<p>Quality Assurance Inspector</p> <p></p>
Halo Pharmaceuticals
09.2016 - 09.2018
SUNY Empire State College, Business Administration, BA
09.2014 - 12.2022
<p>Lead Manufacturing Operator</p> <p></p>
Novartis Pharmaceuticals
11.2005 - 08.2016
Rockland Community College, Liberal Arts, AA
09.2005 - 05.2010
<p>Lead Aseptic Operator</p>
Wyeth Pharmaceuticals
02.2002 - 11.2005
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