QA Technician II

Thermo Fisher Scientific•Lenexa, KS

4d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: SDG- MBD Lenexa location 12076 Santa Fe Dr. Lenexa KS 66215 How Will You Make an Impact?: The QA Technician will review batch records, identify documentation errors, and coordinate with Operations to resolve errors or raise issues as part of the quality assessment of products. This person will also be responsible for filing and document retrieval as needed. The QA Technician requires excellent attention to detail, organizational skills and interpersonal skills to ensure timely and accurate evaluation of documentation.

Requirements

High School Diploma or equivalent.
Working knowledge of various computer software programs such as Teams and Excel.
Self Motivated and able to work in a team environment
Able to work in filing room environment and lift 50 lbs for document archival, as needed (This is not a lab based position: This role focuses on Documentations analysis and SOP compliance)

Nice To Haves

1+ years of experience in QA, QC, or manufacturing within a regulated environment such as medical device, pharmaceutical, or food manufacturing.
Background in Medical device, cGMP, or ISO certified environment.
Data entry skills and familiarity with inventory management systems such as SAP.
Proven ability to work effectively as a member of a cross-functional team.

Responsibilities

Review production batch documentation for compliance with cGMP good documentation requirements.
Communicate effectively and coordinate tasks with Manufacturing and Quality Control to facilitate timely release of products.
Process 100% inspection rework activities and stock adjustments.
Track and trend functional metrics.
Support compliance initiatives and Regulatory and Customer Audits.
Assist with continuous improvement projects and participate in lean activities.