Document Control Administrator II

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Marietta, OH
In-Office
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join Thermo Fisher Scientific to contribute globally, making a positive impact daily.

Location/Division Specific Information:

Marietta Manufacturing site is in the Laboratory Products Division, providing equipment for pharmaceutical and biotechnology research.

How Will You Make an Impact?:

In this role, you will play a crucial part in ensuring flawless documentation practices, which are essential for maintaining our world-class standards. Your meticulous attention to detail will help us strictly adhere to regulatory requirements and successfully implement continuous improvement initiatives.

You will ensure that all documents are accurate, up-to-date, and aligned with industry standards and regulations, reducing the risk of non-compliance issues.

You will improve communication and collaboration across departments by providing easy access to accurate and consistent documentation.

By implementing efficient document control processes and systems, you will help streamline workflows, reduce redundancies, and improve overall efficiency.

By managing project documentation effectively, you will support project managers in meeting deadlines and achieving project goals

A Day in the Life:

  • Review DHR’s for Good Documentation Practice and Good Manufacturing Practice.
  • Inspect, measure, and report Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) performance of reviewed records.
  • File records (electronic or hard copy) in designated locations, retrieve as necessary to support the business.
  • Perform and record inspections / acceptance, control, and release of manuals.
  • Identify, error-check, log, and file documents critical to GMP compliance.
  • Assist in the creation, revision, and formatting of standard operating procedures (SOPs), work instructions, and other controlled documents.
  • Lead change control processes, ensuring that all document changes are accurately reviewed, approved, and implemented.
  • Handle the retention and archiving of documents in accordance with company policies and regulatory requirements.
  • Participate in continuous improvement initiatives to improve document control processes and systems.
  • Stay updated with regulatory requirements and industry standards to ensure ongoing compliance.
  • Work closely with other departments, such as Quality Assurance, Manufacturing, and Supervisor/Managers, to ensure document control processes align with their needs.
  • Monitor and report on critical metrics linked to document control activities.

Education:

High school diploma or equivalent experience required.

Experience:

  • Required: Minimum of 1 year of work experience in QA or QC or related field
  • Preferred: Experience in a cGMP environment

Knowledge, Skills, Abilities:

  • SAP experience, desired
  • Strong attention to detail
  • Written and verbal communication skills
  • Experience with Microsoft Office

Physical Requirements / Work Environment

  • Ability to lift up to 35 lbs unassisted, unpackage / repackage materials

What We Offer

Compensation

  • Competitive Hourly Pay Rate
  • Annual performance-based bonus
  • Annual merit performance-based increase

Excellent Benefits

  • Benefits & Total Rewards | Thermo Fisher Scientific
  • Medical, Dental, & Vision benefits-effective Day 1
  • Paid Time Off & Designated Paid Holidays
  • Retirement Savings Plan
  • Tuition Reimbursement
  • Employee Referral Bonus
  • Career Advancement Opportunities

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.

Accessibility/Disability Access

Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations during the application process. This includes help for hearing, vision, mobility, or cognitive challenges.

  • Dedicated telephone line for job seekers with disabilities needing application process accommodations.

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The Company
HQ: Waltham, MA
100,000 Employees

What We Do

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.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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