Thermo Fisher Scientific Job - 41138430 | CareerArc
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Company: Thermo Fisher Scientific
Location: Indianapolis, IN
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Summary:

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).

Essential Functions:

  • 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.

Education:

High school degree

Experience:

Two years of production or quality experience. Preferably in a GxP manufacturing or packaging industry.

Competencies:

  • 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.

Physical Requirements:

  • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and operational locations; ability to stand, site or walk for prolonged periods of time. Some manipulation (lift, carry, move) of light to medium weights of 5-25 pounds may be necessary.
  • Hand and finger dexterity, including visual acuity to use a keyboard, computer monitor, and read materials for prolonged periods of time.
  • Minimum vision requirements for the role include Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or less), color vision and ability to adjust focus.
  • Requires proof of Covid-19 vaccination by {11/15/2021}

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


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