MedPharm

QA Specialist I

MedPharm Durham, NC
MedPharm

QA Specialist I

MedPharm Durham, NC
3 weeks ago
Over 200 applicants

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Wendy Ward Click here to view Wendy Ward’s profile

Wendy Ward

Human Resources Manager at MedPharm

  • Follows, adheres and enforces GLP, GMP, GDP, USP, ICH guidelines, MedPharm procedures and Policies.
  • Adheres to MedPharm Health & Safety Policy and OSHA regulations at all times and to ensure the safety of others in any procedures or tasks performed.
  • Review of GLP quality related documents, including but not limited to study protocols and amendments, study reports, deviations, validation reports and other relevant documents as needed.
  • Review and approval of analytical documentation including methods, validation protocols, analytical data and reports (release, stability and validation) for GMP and GLP activities.
  • Performs facility and system audits as defined by procedures and Quality Plans and generate reports to document findings.
  • Participates in cross functional teams to identify and resolve quality issues as they present themselves, exercise judgement within defined policies, procedures and practices to determine appropriate action (s).
  • Identify documentation issues and ensure notification is made to the appropriate personnel.
  • Participates, generates and/or review investigations, root cause analysis, Corrective and Preventive Action (CAPA) plans related to process / product deviations, material testing, and laboratory results
  • Coordinate with other departments as required to resolve issues and compliance concerns detected during GXP documentation review.
  • Participates in the generation and review of trending reports (i.e. process trending, environmental trends, water quality trends, Complaint trending etc.).
  • Writes and /or contributes to the creation or revision of Standard Operating Procedures, policies and quality related documents applicable.
  • Escalates any quality issues immediately to Quality Assurance management
  • Maintain knowledge of current regulatory requirements pertaining to pharmaceutical manufacture.
  • Maintain effective communication and partnership with all departments across the organization
  • Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations.
  • Provides support for regulatory inspections and client audits.
  • Serves as an Archivist or Back-up archivist and performs document-controlled activities as needed.
  • To perform any other tasks at the request of MedPharm senior management appropriate to the job function.

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • 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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