Senior QA Specialist; Technical Writer

Senior Quality Assurance Specialist – Sterile Manufacturing

Location: Morrisville, NC (Fully onsite)

Schedule: Monday–Friday, 8:00 AM – 5:00 PM

Pay Rate: $35–$47/hour

Type: 6-Month Contract (Fully Benefited)

This on-site position is responsible for driving quality and compliance initiatives within a sterile pharmaceutical manufacturing environment. The Senior Quality Assurance (QA) Specialist ensures compliance with cGMP regulations and internal procedures by performing document review, internal audits, visual inspection of sterile drug products, and contributing to continuous improvement efforts. This role plays a key part in maintaining a strong quality culture and supporting regulatory inspection readiness, particularly in environments requiring Grade C gowning and aseptic handling
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• Perform quality review and approval of GMP documentation, including batch records, logbooks, forms, protocols, and reports.
• Issue and control GMP documents to support manufacturing operations in sterile cleanroom environments.
• Conduct visual inspections of parenteral drug products (qualification required) for defects or particulate contamination.
• Execute internal audits and support external client and regulatory inspections.
• Maintain and update quality databases and ensure proper document control.
• Provide floor support to manufacturing teams and guide adherence to aseptic techniques and cleanroom behavior.
• Assist in the development and revision of SOPs, forms, and quality procedures to meet regulatory standards and improve processes.
• Collaborate cross-functionally to support batch review, deviation resolution, CAPAs, training, and vendor qualification efforts.
• Serve as a mentor or resource for less experienced QA team members.

• Bachelor’s degree in Chemistry, Biology, or a related field;
  Master’s degree preferred.
• Minimum 5+ years of GMP experience in quality assurance, preferably in sterile manufacturing.
• Familiarity with Annex 1, aseptic processing, and Grade C gowning requirements.
• Ability to meet visual inspection standards (20/20 corrected vision).
• Strong understanding of FDA and international cGMP regulations.
• Experience working in environments requiring strict contamination control.

• Full-time, 100% on-site position.
• Frequent standing, occasional sitting, walking, kneeling, or crouching.
• Regular lifting of up to 10–25 lbs; occasional lifting of up to 50 lbs.
• Exposure to cleanroom environments, moving equipment, potential chemical or biohazardous materials.
• Use of Personal Protective Equipment (PPE) required (gowns, respirators, gloves, etc.).

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

Employees are entitled to earn paid sick leave under the applicable state or local plan.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce.

Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.