Quality Oversight Specialist Position Available In Wake, North Carolina

Quality Oversight Specialist

Holly Springs, NC Date Posted:

19-Jun-2025

Work Type:

On-Site

Job Number:

457926
Job Description

Title:

Quality Oversight 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. Basic Qualifications
Doctorate degree OR
Master’s degree and 3 years of directly related experience OR
Bachelor’s degree and 5 years of directly related experience OR
Associate degree and 10 years of experience OR
High school diploma / GED and 12 years of experience 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 Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $30.00/hr.