Regulatory & Quality Document Control Spec.


Full time

Framingham, MA

The Regulatory & Quality Document Control Specialist will be responsible for regulatory and quality assurance documentation activities.  This individual will prepare, process, organize and track documents received (paper and electronic) as per project guidelines in a timely manner. They will ensure that documents are scanned, imported, coded, indexed, and reviewed for quality. They will ensure documents are stored into their pertinent drives including and not limited to the Trial Master File. The ultimate responsibility will be to ensure regulatory inspection readiness.

Responsibilities

  • Coordinate regulatory and quality assurance documentation activities (paper and electronic).
  • Identify and interpret relevant regulatory guidelines.
  • Assist in the preparation and review of regulatory submissions.
  • Participate in writing and implementing Standard Operating Procedures.
  • Recognize opportunities for documentation improvement and helps implement new strategies.
  • Assist in issuance, tracking, and archiving of laboratory notebooks.
  • Assist with day-to-day Document Control activities. Ensure documents are routed, reviewed, approved and obsoleted in accordance with BERG Standard Operating Procedures.
  • Assist in document archival of records at off-site storage per GxP regulations.
  • Other duties, as assigned.
  • Performs verification and quality control of essential regulatory documents and organization of a Trial Master File (TMF)/electronic Trial Master File (eTMF).
  • Manages the eTMF systems and ensures TMF Inspection Readiness is current, and “inspection ready”, at all times.
  • Responsible for scanning, organizing, and uploading documents.
  • Responsible for ensuring documents are complete, contemporaneous, and quality ensured.
  • Ensures key performance indicators (KPIs)are met.
  • Build collaborative relationships with cross-functional teams.
  • Provide support to Clinical Operations process implementation, audits, and/or regulatory inspections.
  • Ensure functional compliance supporting guidance and applicable global regulations.
  • Perform risk-based quality content reviews and monitor internal/external KPIs.
  • Representative in operations at study team meetings as needed, participate in collaborative efforts, and play a cross-functional role in document retrieval and management.
  • Ensure documents that fail quality content and/or inspection readiness review are effectively remediated by internal/external representatives.
  • Monitor and identify study-specific trends and escalate concerns to the Head of Operations.
  • Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies.
  • Other duties as assigned.

Qualifications

  • BS/BA Degree required in life sciences
  • Entry-level role with 0 to 3 years of industry experience.
  • Organizational skills and structured work habits.
  • Ability to work on multiple projects at the same time.
  • Ability to maintain a high level of accuracy and attention to detail in a fast-paced environment.
  • Proven computer skills and knowledge of Microsoft Office Suite (e.g. Word, Excel, PPT)
  • Strong communication skills, both verbal and written

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