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Senior Quality Assurance Specialist – Sterile Manufacturing

**Location:** Morrisville, NC

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

**Pay Rate:** $35–$45/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. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.