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

1. Experience in GMP document review and approval
2. General knowledge of cGMP and regulatory filing requirements in biopharmaceutical manufacturing, testing, and distribution
3. Strong leadership, analytical, problem-solving, and customer service skills in a matrix-managed GMP environment