Mollyne Muthuri

ality Assurance Specialist

763-***-****

ABOUT ME

ad26df@r.postjobfree.com

***** ****** **. *****

Andover MN

I am a highly motivated, committed, dedicated and enthusiastic individual who is a quick, detail oriented and keen learner. I demonstrate abilities to outperform expectations. I work well and communicate effectively with all cultures and nationalities in an organization creating a positive work environment. I possess high emotional quotient and relate well to all hierarchy with the ability to create a cohesive working ambience. From my experience below, it is evident that I am loyal to the organization and adaptable to any environment.

SKILLS

•Manufacturing experience.

•Knowledge of Computers, (word, excel, adobe,)

•ERP system knowledge

•CNC

•Documentation.

•Knowledge of GMP and lean manufacturing.

•Knowledge ISO13485/ISO 9001 Standards

•Knowledge of FDA regulations & requirement in Medical industry.

•Tooling

•Detail oriented

•Environmental monitoring.

•Able to recognize major and minor defects in product workmanship.

•Ability to work independently and in a team.

EDUCATION

ARCC -2022- ongoing. (. Associates BMED)

ARCC-Biomedical Core- Certificate

Universal Computer College

Computer applications (Ms word, Excel, PowerPoint, share point, Adobe, CorelDraw).

Mikinduri Girls High school (1991-1994) High School Diploma

EXPERIENCE

Bayer Healthcare 8880 Evergreen Blvd,

Coon Rapids MN 55433

Quality Technician -10/21/2013 – 02/13/2015

Inspecting subassemblies by using templates or reading measurements during assembly.

Conserving resources by using equipment and supplies as needed to accomplish job results.

Documenting activities by completing production and quality forms.

Verifying specifications by measuring completed components and testing

Use of precision tools (calipers, micrometer, microscope, metric chart, pin gauges, ring gauge, force gauges, pressure gauges and laser micrometer).

Preparing work to be completed by studying assembly instructions and parts lists

Putting work order together.

Review of work orders.

Preparing NCRs.

Completion of rework paper work.

Reviewing and releasing SOPs and QSFs.

Saint-Gobain Plymouth, MN- 02/24/15 – 4/22/2022

Highway 55 55441 Plymouth.

Quality Control Specialist

Ability to read and understand WIs and use them to complete & review batch records.

Create and maintain incoming raw material files - Receiving inspection.

Put work instructions together for product assembly.

Review customer drawing for accuracy before customer approval.

Review work orders/batch records for completeness.

Maintains training records including training matrix and training files.

Review and Release documents, QSDs, SOPs, QSFs.

Review and process validation reports.

Maintain calibration records.

Perform QA document control functions, including document login, tracking, processing, review, distribution, release, obsolete and archiving of documents.

Update SOPs and work instructions.

Training quality inspectors.

Do Environmental monitoring and maintain all records.

Complete quality checks such as 1st Article inspection and final inspection.

Maintenance and review of DHR.

Opening NCRs and closing NCRs

RMA verifications and maintenance.

Opening CAPA and participate in implementation.

Manage external and internal testing of products. (Destructive testing).

Review sterilization Reports (COP) for dosage, lot #’s, & Quantities.

Release raw materials and finished goods in QAD(ERP) system.

Organize and maintain reliable filing systems for all paper based GMP documents.

Maintain change control and deviation processes for SOPs.

Actively participates in internal audits and other activities as assigned by QA manager.

Able to assemble and function test medical devices.

Flexible schedule.

Diamond Graphics LLC. 4/25/22- Present

Quality Assurance Specialist

Release of finished product.

Review Data

Review customer complains.

Job approvals and sign offs

Reconciliation of data, materials, production paper work and certification.

Do internal process audits.

Assist with continuous improvement process for document control and record management.

Ensure compliance with procedures and applicable industry regulations.

Review internal documentation, confirmation of compliance and resolution of deficiencies.

Assist with documentation for offsite storage transfer.

Implementation of Quality documents.

Report and manage quality issues, trends, and effectiveness.

Support quality requirements of products, ensure product meet key quality metrics prior to commercial release.

Hobbies

•Playing and watching basketball

•Watching soccer and movies.

•Reading.

References

Amos Kithinji

Cell: 763-***-****

Olu Akande

Cell:952-***-****

Amino Haji

Cell: 612-***-****

Contact this candidate