Senior QA Specialist; Technical Writer

Position: 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)

*
* Job Summary:

*
* ** 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**  **.*
* *
* Key Responsibilities:

*
* + 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.

*
* Qualifications:

*
* + 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.

** Work Conditions &

Physical Requirements:

*
* + 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.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.  ()  for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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