Sr QA Technician - 1st & 2nd Shift

Thermo Fisher Scientific•Indianapolis, IN

1d•Onsite

About The Position

The Quality Assurance Specialist role is responsible for the Quality Assurance activities that support the site’s operations such as material/components/label receipt, in-process control checks and oversight of operational execution, cleaning/clearance, etc. Partners internally to identify and resolve issues that are identified during site material handling and operational activities. Supports the site’s execution of the principles of current Good Manufacturing Practices (cGMP). This position is located in Indianapolis, IN/ PSG/CTD.

Requirements

Ability to partner and communicate with team members and other functional areas.
Familiarity with cGMPs and Quality Management System tools/applications (e.g. TrackWise, Documentum, etc.) and basic computer skills.
Ability to multi-task and effectively prioritize activities for self and team.
Ability to lift 40 lbs. without assistance
High school diploma or equivalent required
Minimum of 2 years of work experience in QA or QC or related field

Nice To Haves

Experience in a cGMP environment

Responsibilities

Ensure appropriate execution of the Quality Systems to sustain cGMP compliance.
Supports the cGMP document (SOPs, Forms, Logbooks, Batch records, etc.) control processes used during operational activities.
Perform packaging start-up checks, in-process Quality checks and accountability.
Perform AQL sampling and inspection activities during operation activities.
Ensures Label Document Compliance through examination of Label Specifications, Master Label Proofs, Randomizations, and Links Reports.
Review and approval of printed labels, printed packaging components and Fisher-supplied packaging components.
Provide assistance and guidance on quality issues or documentation for Operations.
Identify deviations and escalate issues to Quality Assurance Representative and/or Quality Manager.
Performs all job responsibilities with integrity and intensity keeping a focus on Quality and Safety for employees.
Embraces opportunities and other activities requested by leadership to support business needs.