Document Control Specialist

2 weeks ago

Atlanta, United States Randstad Life Sciences US Full time

Document Specialist

Duration: Direct hire

Location: Fully onsite in Atlanta


Must haves:

  • Some document control and records management responsibilities in past role
  • Technical knowledge of Microsoft Word
  • Willing and eager to learn
  • Picks up on things quickly
  • Ability to work in a fast paced environment


Summary:

Our client is currently seeking a highly skilled and detail-oriented Document Specialist to join their dynamic team. As a Document Specialist, you will develop and maintain document and record control systems in the FDA regulated biologics, pharmaceutical, and medical device industries.


Responsibilities:

  • Maintain document control systems (electronic/paper) compliant with regulatory requirements and company procedures/systems.
  • Maintain external documents compliant with regulatory requirements and company procedures/systems.
  • Maintain record control systems (electronic/paper) compliant with regulatory requirements and company procedures.
  • Maintain sample control systems compliant with regulatory requirements and company procedures/systems.
  • Maintain training matrices (electronic/paper) compliant with regulatory requirements and company procedures.
  • Creates, reviews, and approves documents – procedures, protocols, reports, etc.
  • Quality assurance review and disposition of products.
  • Represents Quality on intra-/inter-departmental project teams.
  • Conduct company-wide training (e.g., documents, records, and specimens/samples).
  • Conducts internal and supplier audits.
  • Ensures in a positive way compliance with regulatory/standards requirements and company procedures.
  • Participates in professional organizations to ensure that state-of-the-art industry regulatory/standards requirements are communicated within the company and implemented in an efficient, timely, and accurate manner.
  • Manages projects as assigned.
  • Maintain and present quality indicator metrics.
  • Has some independence for unreviewed action or decision.
  • Effectively manage time and multiple task assignments.
  • Other duties as assigned by management.


Qualifications:

Education:

  • Bachelor (or equivalent) degree in English/Technical writing with ≥5 years’ experience with document and records control in regulated industry.


Experience:

  • Experience in document and records control.
  • Working knowledge and experience with GMP or QSR / ISO 13485 or ISO 9001 required; GLP, GCP, and related ISO and ICH preferred.
  • Working knowledge and experience with paper-/electronic-based document management systems.
  • Excellent communication skills (oral, written, and presentation) and understands how to present information dependent upon the level of the audience.
  • Must be detail oriented with excellent organizational skills.
  • Must be able to work independently as well as in a team environment.
  • Expert: MS Word, MS Excel, MS Power Point, Adobe and/or Adobe Creative Suite.
  • Design/create product labels, product labeling (e.g., IFU, product inserts), audio-visual trainings
  • Ability to work independently and collaboratively in a fast-paced environment

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