QA Technician II

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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.

Key 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.
Minimum 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)

Requirements:

Education:

High School Diploma or GED Required

Preferred Requirements:
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.
Physical Requirements:
Work requires recurring bending crouching stretching or reaching. Or may frequently operate equipment including keyboard with mouse and must walk sit or stand immobile for prolonged periods. Usually in a comfortable environment but does require time on production floor to collect documentation. Frequent need to distinguish among or interpret a variety of sensory inputs that require attention to decode and identify. (e.g. reading handwritten values reviewing balance sheets).

What We Offer:

Compensation
Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase

Excellent Benefits
Medical benefits
Paid Time Off/Annual Leave
Employee Referral Bonus
Career Advancement Opportunities