23 days old

GMP QA Specialist

Kelly Services
Austin, TX 78703
**Kelly Services** is currently seeking a **QA Specialist** in **Austin, TX** to work a contract assignment 12 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities includes:**

Duties may include oversight of various aspects of change control and documentation, including but not limited to change control administration, records management, document control, local change control, and corporate change control. As a member of the Quality unit this individual is accountable for ensuring that changes made to processes, products or systems have been properly reviewed and approved to maintain proper cGMP control of validated systems. The Change Control specialist is responsible for supervision of the daily activities of the Documentation Technicians.

ESSENTIAL JOB FUNCTIONS: Administers the local change control system, records management system, and/or documentation system.Ensures Corporate changes relating to Austin processes are reviewed for impact and that Austin commitments are appropriately tracked to completion. Ensures consistency and compliance of changes with local, corporate and global regulatory requirements CFR, PIC/s, etc. Evaluate process/procedure changes as necessary. Drive continuous improvement of departmental processes.

OTHER DUTIES AND RESPONSIBILITIES: 1. Come to agreement by managing communications through discussions and compromise.2. Investigate exceptions related to the documentation center or various change control processes to determine root cause and appropriate corrective action s .3. Write or assist with the writing of Standard Operating Procedures 4. Perform other related duties as assigned or required.

EXPERIENCE OR KNOWLEDGE REQUIRED IN THE DISCIPLINE OR FUNCTION:3-5 years of Quality experience in a regulated environment FDA regulated environment preferred . High level of attention to detail and the ability to prioritize and manage heavy workloads in a dynamic environment. Must have thorough knowledge and understanding of cGMPs, FDA and/or pharmaceutical industry guidelines. Must have good organizational, presentation, project management, and meeting facilitation skills.


**For immediate consideration please send your resume in a WORD document to**

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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. 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: 2020-09-28 Expires: 2020-10-29

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GMP QA Specialist

Kelly Services
Austin, TX 78703

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