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Document Control Administrator II - 2nd Shift

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Thermo Fisher Scientific

12d ago

  • Job
    Full-time
    Entry & Junior Level
  • Research & Development
  • St. Louis

AI generated summary

  • You need a high school diploma, 0-2 years of relevant experience, GMP knowledge, MS Office/Smartsheet proficiency, ability to lift 40 lbs, and strong communication skills.
  • You will scan, archive, and manage cGMP documents, create labels, ensure compliance, perform cleaning, maintain records, participate in safety activities, and provide on-call support as needed.

Requirements

  • - Able to lift 40 lbs. without assistance
  • - Adherence to all Good Manufacturing Practices (GMP) Safety Standards
  • - High school diploma or equivalent experience required
  • - 0-2 years of relevant experience, or equivalent combination of education and experience
  • - Experience in quality, manufacturing, and/or GMP environment preferred
  • - Understanding of cGMP practices and proper documentation procedures
  • - Proficient in MS Office and Smartsheet
  • - Ability to effectively multi-task and communicate clearly
  • - This role involves occasional heavy lifting or moving and requires adherence to safety procedures, including the use of Personal Protective Equipment

Responsibilities

  • Scan and archive batch records and other cGMP documents.
  • Organize, pack, ship, and receive batch records.
  • 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 driven 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.

FAQs

What is the work schedule for the Document Control Administrator II position?

The work schedule is standard Monday through Friday, specifically during the 2nd shift from 2pm to 10:30pm.

What are the physical requirements for this job?

Candidates must be able to lift 40 lbs. without assistance and adhere to safety procedures, including wearing Personal Protective Equipment when required.

Is experience in a GMP environment required for this role?

While 0-2 years of relevant experience is required, experience in quality, manufacturing, and/or a GMP environment is preferred but not mandatory.

What types of tasks will I be performing in this role?

The role involves scanning and archiving documents, organizing and shipping batch records, creating and canceling labels using SAP and Sample Manager, issuing logbooks and batch records, and ensuring compliance with cGMP requirements.

Are there opportunities for career development at Thermo Fisher Scientific?

Yes, Thermo Fisher Scientific offers outstanding career and development prospects, providing resources and opportunities for colleagues to grow and make a difference.

What are the keys to success for this role?

Keys to success include strong organizational and prioritization skills, diligence with a focus on safety, and the ability to work independently as well as part of a team.

What sort of benefits does Thermo Fisher Scientific offer?

Benefits include competitive remuneration, an annual incentive plan bonus, healthcare, and a range of additional employee benefits.

Will training be provided for this position?

Yes, training on the 1st shift will be provided to learn crucial job functions for a reasonable period of time.

What is the location of this job?

This position is based in St. Louis, MO, within the division dedicated to the production of commercial and clinical biologics.

Is there a requirement for on-call coverage in this role?

Yes, candidates must be available for on-call coverage during off-shifts.

Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.