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QAD Tech II

4 months ago

St Louis, Missouri, United States Thermo Fisher Scientific Full time

Job Description

Job Title: Quality Assurance Documentation Technician II

Work Shift (Monday-Friday) / 2nd Shift (2pm-10:30pm)

At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

St. Louis, MO

Discover Impactful Work:

Responsible for the routine daily performance of document issuance in support of the manufacture of commercial and clinical biologics. These support activities consist of issuing and printing batch records, sample labels and other supporting documents used by various departments in the production processes per established standard operations procedures and in compliance with cGMP documentation practices.

A day in the Life:
  • Scan and archive batch records and other cGMP documents.
  • Organize, pack, ship and receive batch records and other cGMP documents.
  • Perform sample and product label creation and cancellation using SAP and Sample Manager systems.
  • Issue and prepare of logbooks, batch records, high risk forms and other cGMP documents with "right the first time" execution as needed.
  • Perform review process and assign effective dates to batch records and other cGMP documents.
  • Document all activities to meet cGMP requirements.
  • Maintain cGMP compliance in assigned work and follow all safety procedures, to include the use of Person Protective Equipment, if required.
  • Perform basic routine cleaning and organizing of archive rooms.
  • Perform complete reconciliation process of executed batch records and other cGMP documents.
  • Participate in cross-functional activities.
  • Maintain up to date training records.
  • Participate in other required activities (perform safety inspections, participate in improvement projects, etc.).
  • Participate in shift exchanges, 1-1's, and meetings.
  • Be available for on-call coverage on off-shifts
  • Be able to train on 1st shift to learn crucial job functions for a reasonable period of time
Keys to Success:Education
  • High school diploma or equivalent required.
  • 1-3 years of proven experience, or equivalent combination of education and experience required
  • Experience in quality, manufacturing and/or GMP environment preferred
Experience
  • Scanning and archiving
  • Document Issuance and Control
  • Quality/cGMP Documentation
Knowledge, Skills, Abilities
  • Mechanical Skills/ Analytical Skills/Method Automation
  • MS Office
  • Strong organizational skills
  • Strong prioritization skills
  • Detail oriented
  • Results driven
  • Safety Mentality
  • Smartsheet
  • Sample Manager
  • Able to read, write, and communicate in English
  • Able to understand and carry out instructions
  • Reliable
  • Strong communication (written and verbal)
  • Effectively multi-task
  • Able to work in an environment of change
  • Able to work independently and as part of a team
  • Able to recognize problems developing, not just occurring
  • Occasional heavy lifting or moving required
Physical Requirements / Work Environment
  • Ability to sit for extended period of time
  • Ability to lift 20lbs or more
  • Ability push, pull, bend and reach overhead
Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.