Quality Manager
Resume:
MATTHEW ARCHAMBAULT
Orange MA, 01364
Mobile: 978-***-****
Home: 978-***-****
*******************@*****.***
TECHNICAL SKILLS
Computer skills: MFG Pro, 4D Documentation Database, Microsoft Word, Power Point, Excel, Ross, Master Control, iLIMS
Experience with product labeling for drug products, medical devices and solar panels
Lean manufacturing protocol (6S)
Flow meter, systems with valves, pressure gauges, pumps, spectrometer, calipers, ABL835 Blood Analyzers, ABL90 Analyzers, YSI 2300, Nova 8, Incubators, Spectrophotometer, Dilutor, Minivis, Pycnometer, Minivis Data Capture
TSA Certified
Experienced with 21 CFR Part 11, Parts 210 &211, Part 600, Part 820
PROFESSIONAL EXPERIENCE
Possess twelve years of experience in inspection, quality assurance, and compliance ensuring adherence to 21 CFR Parts 11, 210, 211, 600, and 820. Ability to maintain quality documentation and functionality of instrumentation at cGMP environments to ensure product label accuracy for hundreds of thousands of vials being shipped for the therapeutic treatment of patients. Review of batch records and temperature excursion charts to ensure product strength, integrity, stability, safety, purity, and quality is maintained. Monitoring of all production areas via Environmental Monitoring to ensure product integrity. Perform Stability Testing and capturing of data for use in generation of C of A and C of C’s. Create nonconformance reports when applicable, participate in audits, and complete delegated tasks in change control management systems. Became a spokesperson and liaison between manufacturing, distribution, and quality teams to ensure unity and cross functionality. Presented information in a group setting as appropriate to these teams to ensure common goals and functionalities were understood.
QC Microbiology Technician
Sanofi-Allston, MA Feb 2018-Present
Perform daily incubation and reading of Environmental Monitoring plates
Perform multiple assays to support QC Micro functions
Trend all EM data including Biological Indicators, Cell Cultures and Water for Injection RODAC plates on iLIMS software
Record and Elevate all OOS findings with appropriate capture system, (NCMR’s, CAPA’s etc)
Quality Technician III
Bio-Techne -Devens, MA May 2015-October 2017
Perform daily Blood Gas final testing
Monitor and maintain Temperature monitoring system to ensure stability requirements.
Maintain electronic and physical organization of field released retain material.
Participate in daily in-process run productions of blood and glucose material
Launched and create Technical Reports to upgrade instrumentation to newer customer approved models
Generated Certificates of Analysis certifying product had met all technical requirements
Author and review documents (SOP, Nonconformance Reports, CAPAs, and Quality Logs).
Buffer and Reagent replacement as necessary as well as PM on all analytical machines.
Ordering and maintaining of all laboratory supplies
Quality Inspector
CutisPharma – Wilmington, MA October 2014 – May 2015
(Moved closer to home)
Author and review documents (SOP, Nonconformance Reports, CAPAs, and Quality Logs).
Responsible for the creation of a label inventory system.
Inspection of all incoming material (non-compounded drug, components, and ancillary items).
Compounding and analysis of suspension material.
Initiate and complete all tasks associated with material that is found to be out of specification (OOS).
Quality Control
Spyglass (employee at Bionostics) – Devens, MA May 2014-Oct 2014
(Left for full time opportunity)
Perform quality control assays:
diabetic glucose control testing
Specific gravity and viscosity testing
Organization of past retain samples based on expiration dates.
Monitor, evaluate, and improve the quality system according to cGMP regulations.
Sustain quality record information.
Maintain cGMP compliance.
Coordinate with peers to ensure timelines are met.
Quality Specialist
Randstand (employee at Genzyme) - Northborough, MA April 2012 – December 2013
(Production moved to Pennsylvania)
Monitor, evaluate, and improve the quality system according to cGMP regulations (21 CFR Part 11, Parts 210 & 211, and Part 600).
Perform batch record reviews and final release for all CTM labeled and packaged product, as well as incoming products, components.
Inspect and release incoming materials and printed labels received by SQO operations staff.
Review, maintain and archive all quality records (electronic and paper).
Enter information into the Product Specification Files so that all information is current and up to date.
Prepare, revise, and master quality documents using appropriate change control when necessary.
Support training requirements, informing management of training deficiencies.
Update Quality/Technical Agreements as requested by Sr. QA Specialist or QA management.
Verify packaged lots have been randomized and kit codes, when required, have been properly assigned.
Trend information related to the Quality Management System (QMS) and produce metrics.
Review and approve incoming transfer receipts.
Coordinate and delegate tasks to ensure closure of CAPAs within their designated deadlines.
Supporting role during external audits providing requested information.
Performed internal audits and issued and tracked Non Conformance Reports (NCR) and deviations
Documentation Specialist
Aerotek (employee at Sekisui) - Framingham, MA March 2011 – March 2012
(Company moved Overseas)
Primary user of Optel Vision System for cGMP labeling of products:
Create templates, default scanning parameters, and rejection criteria for cGMP labels
Maintain instrument
Responsible for troubleshooting system failures
Quality assurance review of batch records
Raw material, critical raw material, enzymes
Making process documents effective
Comply with cGMP guidelines, including ISO 9001 regulations
Transfer of product through secure rooms
Certified Quality Control Inspector
Evergreen Solar – Devens, MA February 2010 – March 2011
(Production moved to China)
Accountable for the final product (Solar Panels)
Review of quality documentation
Recorded quality information in the internal data management system
Input data into label templates, print, and label solar panels
Inspected product labels for accuracy
Inspected labeled solar panels to ensure labels were applied correctly
Detect and categorize defects
Responsible for training new hires
Conduct lock-out/tag-out of systems
Lean manufacturing protocol (6S)
Biopharmaceutical Manufacturing Technician
Millipore – Jaffery, NH December 2006– July 2009
Adhere to the cGMP regulations, 21 CFR Part 820
Complete manufacturing of medical grade filters in a cGMP environment
Maintain documentation in accordance with cGMP regulations
Experience with quality documentation of medical devices from early material handling through final testing and sterilization
Independently checked integrity of medical filters by measuring: Air flow, Pressure Drop, Overall Integrity, Delta Thickness, Sterilization
Recorded quality information in the internal data management system according to cGMP guidelines
Routinely interact with quality assurance
Train/mentor junior level staff/new employees
Experience with request forms and reviewing and updating process SOPs
EDUCATION
Fitchburg State College – Graphic Design
REFERENCES
Nelson Perez, Incoming Receiving Specialist, Bio-Techne: 781-***-****
Sandra Skudalski, Supplies Alignment Manager, Bristol Myer Squibb: 1-401-***-****
Don Smith, Sales Manager, Bio-Techne: 1-978-***-****
Colin Boutwell, Quality Inspector, Evergreen Solar: 978-***-****
Contact this candidate