Regulatory Documentation Specialist
Gaithersburg, MD 
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Posted 28 days ago
Job Description
Regulatory Documentation Specialist
Job Locations US-MD-Gaithersburg
Job ID 2022-3240 Department Cell Derivation Unit Posted Date 9/6/2022
Overview

The Regulatory Documentation Specialist is responsible for setting up governing documentation to ensure compliance with applicable regulations related to the receipt, handling, production, and distribution of biological materials. They create documents such as Standard Operating Procedures (SOPs) to meet regulatory compliance and align with organizational policy. They manage filing systems, tracking of all documents on and off-site, and logging of document locations.

The Regulatory Documentation Specialist works on assignments which are semi-routine in nature. They normally follow established procedures on routine work and require instructions on only new assignments. They recognize the need for occasional deviation from accepted practice.

Responsibilities
    Collect, update, process, store, distribute, archive, and maintain documents and records related to regulatory compliance.
  1. Author, review, and revise documentation including SOPs, Work Instructions (WIs), forms, and related departmental documentation.
  2. Ensure information captured is complete and accurate and meets the expectations of applicable regulatory bodies.
  3. Extract, analyze, and summarize information for submission to regulatory agencies or to fulfill other internal or external requests. Assist in coordinating regulatory documents for submissions.
  4. Coordinate timelines, document revisions and review cycles for all documents including delegation to the appropriate groups for review to ensure business continuity.
  5. Support the development of document approval, distribution, modification, retention, and destruction schedules in accordance with internal policies and regulatory requirements.
  6. Solicit and incorporate feedback from cross-functional teams to drive continual improvement of documentation. Utilize internal processes, tools, and procedures to perform document formatting to meet required standards and technical requirements.
  7. Provide technical regulatory documentation support to staff in the interpretation of regulations.
Qualifications

Education and Experience:

  • High School diploma and 2-5 years' experience or equivalent experience.

Other Duties:

  • Perform other duties as assigned.

Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.

ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.


American Type Culture Collection is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
2 to 5 years
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