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9 days old

Quality Assurance Specialist

Kelly Services
Austin, TX 78759
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a **Quality Assurance Engineer Medical Device** at a prestigious Fortune 500 company working in **Austin, TX.**



This is a 6-month temporary position at 40 hours per week.



**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the submit now button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position ( keig126@kellyservices.com ) however your resume must be received via the submit now button included within.



**JOB SUMMARY:**



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.






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



Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.




**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.

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Posted: 2019-11-04 Expires: 2019-12-05

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Quality Assurance Specialist

Kelly Services
Austin, TX 78759

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