Quality Assurance Documentation lll (QAD)

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

Job Title:

Document Control Administrator III (QAD)

Job Description:

Work Shift (Monday-Friday)

Requisition ID:

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 an exciting career with us.

Location/Division Specific Information

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

Discover Impactful Work:

Join our team and contribute to pioneering projects that have real-world impact. As a Document Control Administrator III, you will play a crucial role in ensuring detailed documentation processes, supporting our mission to deliver extraordinary solutions.

A day in the Life:

• 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.
• Perform all document-related tasks such as making documents effective, printing, periodic review, withdrawal, reconciliation, issuance, archiving, scanning, record retention, document release, and accountability.
• 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 (i.e. perform safety inspections, participate in improvement projects, other documentation processes, 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:

• Strong organizational and prioritization skills.
• Diligent with a focus on safety.
• Ability to work independently and as part of a team.

Education

• High school diploma or equivalent experience required.

Experience

• 2+ years of relevant experience.
• Experience in quality, manufacturing, and/or GMP environment preferred.

Knowledge, Skills, Abilities

• Understanding of cGMP practices and proper documentation procedures preferred.
• Proficient in MS Office and Smartsheet.
• Ability to effectively multi-task and communicate clearly.

Physical Requirements / Work Environment

• The position requires basic physical skills like walking, standing, bending, and the ability to lift and carry up to 30 pounds at time. It also requires good hand and finger dexterity for typing, and clear vision for using a computer and reading.

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.