QA Specialist Job Listing at Kelly Services in Winston Salem, NC (Job ID US3608520_BH9784727)

Description

Job Title: QA Specialist II – Contract
Location: Winston Salem, NC
Schedule: Monday–Friday, 8:00 AM – 5:00 PM
Employment Type: Contract
Pay Rate: $30-$33/hour

Position Summary:

The QA Specialist II provides critical Quality Assurance (QA) support to Quality Operations, with a strong emphasis on material and batch release activities. This role is ideal for candidates with a sharp eye for detail, strong documentation skills, and a solid understanding of cGxP regulations in a fast-paced pharmaceutical or life sciences environment. The QA Specialist II helps ensure that products, materials, and processes meet regulatory requirements and internal standards.

Key Responsibilities:

• Maintain GMP databases by ensuring accurate data entry, consistent tracking, and timely follow-up.

• Review completed manufacturing, filling, labeling records, and analytical data for compliance with regulations, SOPs, specifications, and acceptance criteria.

• Review and update GMP system procedures to align with current regulatory and company standards.

• Monitor production and non-production activities for compliance; report non-conformances to Quality Management.

• Ensure finished products meet internal and external compliance standards, including cGxP regulations.

• Prepare and perform initial reviews of documentation related to the release of product lots and vendor materials.

• Support investigations of deviations, including root cause analysis and corrective/preventive actions (CAPA).

• Review SOPs, change control documents, and protocols relevant to cGxP as assigned.

• Report and track key quality metrics and performance indicators.

• Participate in internal, customer, and regulatory audits as assigned.

• Identify compliance risks and communicate them effectively to senior management; support mitigation efforts.

• Collaborate across departments to implement quality and regulatory strategies.

• Escalate critical quality issues promptly for management resolution.

• Stay informed on industry trends, regulations, and methodologies related to GMP and cGxP.

• Support the implementation and continuous improvement of regulated Quality Systems.

Minimum Qualifications:

Education:

• Associate's degree with a minimum of 4 years of relevant experience

• OR Bachelor's degree with a minimum of 2 years of relevant experience

Knowledge:

• Working knowledge of deviation management and CAPA processes

• Familiarity with FDA, EU, and ISO regulatory frameworks is preferred

Skills:

• Strong verbal and written communication skills, with the ability to communicate clearly and professionally

• Ability to prioritize work, meet deadlines, and deliver high-quality results

• Proven ability to manage projects and proactively communicate updates or changes

• Proficient in Microsoft Word, Excel, and Adobe

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 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.

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