Quality Assurance Specialist Position Available In Wake, North Carolina

Job Title:

Quality Assurance Specialist Location:

Holly Springs, NC (Onsite)

Job Summary:

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to support GMP document quality and compliance during site startup activities. This onsite role is critical to ensuring that all GMP documentation meets regulatory standards and aligns with internal quality expectations. The ideal candidate will have strong project management skills, a collaborative mindset, and a deep understanding of cGMP regulations applicable to the biopharmaceutical industry.

Job Responsibilities:

Oversee the quality of GMP documents related to site startup activities.
Review and approve GMP documents, ensuring accuracy and compliance.
Communicate with site SMEs to ensure document adequacy.
Report progress and updates to Senior Management.
Collaborate with various departments within the organization.
Prioritize documents and understand the importance of accurate review process within the required timeframe.

Skills Required:

Strong project management skills and ability to handle multiple projects simultaneously.
Excellent written and verbal communication skills in English.
Ability to work in a team-oriented environment and work effectively with diverse departmental groups.
Proficiency in computer literacy and ability to independently understand, follow and implement instructions.
Outstanding attention to detail and organization skills, effective decision-making skills, focus on process improvements.
Experience in GMP documents review and approval, general knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.

Qualifications:

Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job.
5 years of biopharmaceutical experience responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment is preferred.

About SSi People:

With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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