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Indianapolis, Indiana, USA, United States of America
Onsite
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
1st Shift: Monday to Friday 6:30AM to 3:15PM
2nd Shift: Monday - Thursday - 2:45PM to 1:30AM
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.
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).
Location/Division Specific Information:
This position is located in Indianapolis, IN/ PSG/CTD
A Day in the Life:
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.
Minimum Qualifications (including competencies, education, experience, physical 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.
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.
Education: High school diploma or equivalent required Experience: Required:
Minimum of 2 years of work experience in QA or QC or related field Preferred: Experience in a cGMP environment 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
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