Quality Assurance Control
Resume:
Katherine Grenier
Johnston, RI *****
**************@*****.***
Professional Summary
Resourceful and detail oriented, manufacturing professional with 15+ years of experience in quality control, quality assurance, manufacturing, supervision and assembly. I am skilled in GMP, SOP, CAPA, 8D, CAR, cGMP, Delta V, ISO 9001, ISO 13485. I have a proven ability to improve processes and increase efficiency. Proficient with reading blueprints, medical device and computer board assembly, and machine operations. Strong background in customer service and leadership with a meticulous aptitude Willing to relocate: Anywhere
Authorized to work in the US for any employer
Work Experience
Quality Consultant
Amgen-West Greenwich, RI
July 2024 to December 2024
• Provide quality over site to ensure the operation of products are manufactured, tested, stored and distributed according to current applicable regulations.
• Problem solving using 8D.
• Identifying deviations, problem-solving, decision making, time.
• Delta V experience.
• management, communication (CAPA)
• Corrective action reports (CAR)
• Follow strict SOP’s and cGMP processes. Review logbooks, batch records, attachments work orders and other GMP documentation to ensure production records and testing results are complete and accurate.
• Alert management of any deviations to quality or compliance and any safety risks.
• Routinely utilized on a daily basis Microsoft Excel/Spreadsheets to create and edit documents.
• Stay current with any required training.
• Hold daily meetings communicating and collaborating with the PQA shift to ensure tasks are completed. Surgical Manufacturing Specialist
Integra Lifesciences-Mansfield, MA
August 2021 to March 2024
Clean Room Specialist
• Meet with managing teams, evaluate work in process, and determine what is most essential.
• Certified and knowledge of ISO 9001, ISO 13485.
• Mentor and train peers in compliance of SOP.
• Adhere to strict GDP and cGMP.
• Annual and semi-annual audits, identifying areas for improvement and issue to ensure compliance, safety, quality and efficacy (CAPA)
• Make out work orders daily to keep the flow of productivity.
• Investigate deviations, closely inspecting products, documenting findings for QC records.
• Run multiple mass automation machines verifying everything is working properly and while monitoring machine vision on computer.
• Check productivity of teammates and help when needed, fix minor problems, and make necessary adjustments to machinery.
• Inspects products for irregularities, imperfections, or quality concerns.
• Investigate, remedy and resolve quality defects and production issues.
• Experience reading and understanding blueprints.
• Pull samples to be tested.
• Document all productivity using Oracle or Agile.
• Maintain and record information in activity logs to ensure product quality, safety, and efficacy of QA documents.
• Print labels for packaging, checking batch numbers match orders correctly.
• I was able to successfully change our SOP having made a suggestion which effectively cut down on cost and time and boosted quality.
• Also, I made a suggestion which alleviated strain to operators and helped operators to better discern any deviations to products while producing better quality products. PCB Computer Board Assembler, Tester, and Silicon Coating Hayward Industries-Kingston, RI
March 2021 to July 2021
· Assembled computer boards following SOP.
· Test components on boards in computer system.
· Analyzed what needed attention to ensure quality products.
· Used small hand tools, cutters, and shears to assemble and fix remote controls for cleaning systems.
· Inspected products for safety concerns and irregularities.
· Soldered any incorrect boards.
· Ran silicon coating machine.
· Filled machine with necessary liquids and boards to be coated.
· Disposed of any hazardous waste adhering to strict GMP and complied with all safety regulations.
· Input correct program for coating machine.
· Filled in other rolls as needed.
Machine Operator/Assembler Lead
Honeywell-Smithfield, RI
July 2020 to March 2021
• Operator of eight different machines in the assembly of N95 masks.
• Maintaining proper function of machinery and adjusted when needed.
• Managed production line and filled in where needed.
• Trained new hires.
• Performed daily safe shut down of lines.
• Maintained activity log.
• Inspected materials and final product for irregularities, inclusions, and proper assembly of N95 masks.
• Having a positive and enthusiastic attitude to peers boosting their confidence.
• Held daily meetings with group going over targeted goals.
• Disposal of waste and recorded percentages.
• Inspect for proper sanitizing of work areas.
Homemaker/Caregiver
Home-Scituate, RI
2010 to 2020
I was a stay at home mom and took care of my children at this time. Antique Dealer Owner
Consulting-East Greenwich, RI
January 1999 to January 2010
• Bought and sold antiques and collectibles.
• Interacted with clients/customers.
• Refinished furniture.
• Fixed pottery/statues/stoneware to market as salable items.
• Researched and marketing items.
• Ran estate sales.
• Met the needs of prospective clientele.
• Set pricing.
• Set up for antique shows and sold items.
• Kept financial records.
• Profit and loss.
• Ran advertisements.
Volunteer Teacher for Children with Autism
SPRED – Special people religious education-Greenville, RI August 2008 to May 2009
• Underwent classes to learn how to interact with autistic children.
• Prepared and created lesson plan according to guidelines.
• Managed students that receive special education services.
• Met with parents before and after activities.
• Taught spiritual aspects with pictures, songs, and tangible items.
• This was a very rewarding experience as I saw these children just light up with joy and compassion. Education
BS in Project Management/IT computer science
I am currently enrolled in online courses with Sophia/WGU for BS in Project Management, IT Cyber security.
Skills
• QA/QC
• Oracle
• Blueprint Reading
• CGMP
• Autism Experience
• Agile
• Manufacturing
• Quality Control
• Quality Assurance
Contact this candidate