MedPharm (formerly Tergus Pharma)

QC Technical Writer

MedPharm (formerly Tergus Pharma) Durham, NC
MedPharm (formerly Tergus Pharma)

QC Technical Writer

MedPharm (formerly Tergus Pharma) Durham, NC
3 weeks ago 103 applicants

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Wendy Ward Click here to view Wendy Ward’s profile

Wendy Ward

Human Resources Manager at MedPharm

  • Support Laboratory Quality Systems including change control, investigations, deviations, events, SOP revisions, and documentation practices as part of the quality and compliance objectives.
  • Conduct investigations related to quality systems such as deviations, events, NCRs, CAPAs, OOS, NOEs, complaints, and Quality Protocols of high complexity; works closely with other members of the organization during investigations to determine root cause and potential preventative/corrective actions.
  • Author and review investigations and proposed CAPAs, investigational protocols and reports ensuring conclusions and actions are appropriate for the identified root cause.
  • Responsible for the timely closure of investigations and quality records and filing extensions as needed
  • Author and review stability protocols and reports, Analytical protocols and reports, SOPs, audit responses, and other documents as needed.
  • Support review of analytical methods and specification creation and revisions
  • Guide assigned personnel in conducting thorough, compliant laboratory investigations.
  • Coordinates with QC laboratory personnel
  • Provide weekly summaries of lab incidents and investigations to the Senior Manager and Director.
  • Communicate activities and status on laboratory investigations as required.
  • Responsible for improving and conducting training in analytical techniques, documentation, and regulations, especially those connected with laboratory investigations.
  • Handles and completes special projects as required.
  • Ensure Data Integrity.
  • Supports attainment of team leader goals
  • Work with Microsoft Excel, Word, and possibly PowerPoint
  • Participate in document change control process as needed to maintain document audit readiness/compliance.
  • Working with laboratory CAPA owners to ensure that quality records remain current and present updates at Quality Council meetings.
  • Process document changes and management of changes while ensuring good documentation practices (GDP) within the eQMS system.
  • Other duties as assigned.

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Writing/Editing, Analyst, and Science

  • Industries

    Pharmaceutical Manufacturing

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Featured Benefits

Inferred from the description for this job

  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Disability insurance

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