GMP Documentation Quality Specialist
Title: GMP Documentation Quality Specialist
Location: Holly Springs NC, 27540
Duration- 6 months (Possible Extension)
Overview:
The Quality Oversight Specialist is primarily responsible for the review, approval, and quality oversight of GMP documents related to site startup activities. The role involves cross-functional communication with subject matter experts (SMEs), ensuring document adequacy, and updating senior management on progress.
Key Responsibilities
- Review and approve GMP documents in the applicable GMP system within required timelines.
- Triage documents to determine adequacy against established requirements.
- Communicate with site SMEs to obtain additional information or clarification on GMP documentation.
- Provide timely updates and responses to Senior Manager level stakeholders.
- Collaborate with various departments on GMP documentation.
- Prioritize documents and ensure accuracy in the review process under tight deadlines.
- Perform other duties as assigned by the supervisor.
Preferred Qualifications
- 5+ years of experience in biopharmaceutical quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environments
- Solid understanding of biopharmaceutical bulk manufacturing and distribution processes
- Exceptional attention to detail, decision-making, and organizational skills
- Demonstrated ability to manage multiple complex assignments in a fast-paced setting
- Proficiency in identifying process improvements and escalating issues when necessary
Top 3 Must-Have Skill Sets
- Experience in GMP document review and approval
- General knowledge of cGMP and regulatory filing requirements in biopharmaceutical manufacturing, testing, and distribution
- Strong leadership, analytical, problem-solving, and customer service skills in a matrix-managed GMP environment
Title: GMP Documentation Quality Specialist
Location: Holly Springs NC, 27540
Duration- 6 months (Possible Extension)
Overview:
The Quality Oversight Specialist is primarily responsible for the review, approval, and quality oversight of GMP documents related to site startup activities. The role involves cross-functional communication with subject matter experts (SMEs), ensuring document adequacy, and updating senior management on progress.
Key Responsibilities
- Review and approve GMP documents in the applicable GMP system within required timelines.
- Triage documents to determine adequacy against established requirements.
- Communicate with site SMEs to obtain additional information or clarification on GMP documentation.
- Provide timely updates and responses to Senior Manager level stakeholders.
- Collaborate with various departments on GMP documentation.
- Prioritize documents and ensure accuracy in the review process under tight deadlines.
- Perform other duties as assigned by the supervisor.
Preferred Qualifications
- 5+ years of experience in biopharmaceutical quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environments
- Solid understanding of biopharmaceutical bulk manufacturing and distribution processes
- Exceptional attention to detail, decision-making, and organizational skills
- Demonstrated ability to manage multiple complex assignments in a fast-paced setting
- Proficiency in identifying process improvements and escalating issues when necessary
Top 3 Must-Have Skill Sets
- Experience in GMP document review and approval
- General knowledge of cGMP and regulatory filing requirements in biopharmaceutical manufacturing, testing, and distribution
- Strong leadership, analytical, problem-solving, and customer service skills in a matrix-managed GMP environment