28 days old

Quality Assurance (QA) Specialist

Kelly Services
Plano, TX 75026
Quality Assurance (QA) Specialist

Kelly Science & Clinical is currently recruiting candidates for a **Quality Assurance Specialist** for one of our clients, located in **Plano, TX**

As a Quality Assurance Specialist you will support GMP manufacturing of raw materials and sterile drugs for clinical trials and commercial sterile starting materials. The individual in this role will review documentation related to raw materials, components, and completed batch records. Individual will disposition raw materials, components, and products, as well as, assist with quality systems improvements.

**Duties and responsibilities**

+ Provide direct QA support to manufacturing through inspection, review documentation, and release incoming raw materials and packaging components, as needed.

+ Issuing production related records (i.e. controlled copies)

+ Perform area release for manufacturing, as needed.

+ Review production batch records, logbooks, and associated documentation to assess completeness, accuracy, and compliance with SOPs.

+ Performing secondary review of documentation

+ Follow up on investigations and deviations related to manufacturing activities

+ Release/disposition GMP products for the company

+ Scanning manufacturing batch record documentation such as batch records, raw materials, investigations, and deviations.

+ Provide indirect QA support through

+ Review of equipment and instrumentation documentation in support of GMP manufacturing and testing operations.

+ Review of documentation related to technology transfer from R&D for manufacturing activities.

+ Update Quality SOPS, as needed.

+ Perform directed internal audits of manufacturing and testing operations, as needed

+ Other duties as assigned.

**Required Education and Skills**

+ Bachelor's degree in life sciences or equivalent industry experience

+ 3+ years pharmaceutical QA experience working under GMPs or other closely related environment where documentation and strict SOP adherence are at the core of the business

+ Previous experience with sterile drug manufacturing desirable.

+ Experience in writing SOPs and other associated GMP documentation

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-11-01 Expires: 2021-12-02

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Quality Assurance (QA) Specialist

Kelly Services
Plano, TX 75026

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