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15 days old

QA Engineer-Analytical experience

Kelly Services
Austin, TX 78703
**Kelly Services** is currently seeking a **QA Engineer** 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:**


**How will you make an impact?**


Our commitment to quality is at the heart of our brand and is vital to our growth and success. The role of the Quality Engineer is to support, strengthen and advance the Quality mission, which is enabling our customers to make the world healthier, cleaner, and safer by continuously improving the quality of our products and services. The Quality Engineer will work with various team members, both internal and external customers, with a high degree of professionalism. This is a very hands-on role and works collaboratively with other departments.


**What will you do?**


As a QA Engineer, you will help provide support to ensure the site meets all the requirements for ISO 9001 and 13485, 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA), Quality Systems Regulation (QSR), and USDA regulations. You can help make an impact by providing site QA support including audit readiness, data collection and reporting on Management metrics. Youll also handle & manage complaint cases, investigate, review and approve problem records, CAPAs, and process change orders.


+ Duties will include complaint handling, will work with cross-functional department on complaint cases for investigations, root cause analysis, and corrections/corrective actions to ensure proper documentation and closure, provide trending and escalations as appropriate

+ Analyze and trend all types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects

+ Participate in internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness

+ Participate in third-party audits, external customers, and Agency inspections as needed

+ Support internal Quality activities concerning any identified nonconformities

+ Write and review CAPAs to ensure timely resolution of quality problems

+ Support creation of training plans and update training database to maintain compliance

+ Participate in departmental projects and improvement initiatives through the sites PPI Program and partner with other groups to continuously improve

+ Prepare clearly written business communications, including audit reports, gap assessments, validations, etc.

+ Write, review, analyze and revise written relevant Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Site, Regulatory Requirements as directed

+ Generate and fulfill customer request for COAs, COCs, COOs

+ Perform other duties to support the quality and regulatory department as assigned.


+ Providing Quality oversight for issues of significant scope and complexity across multiple functional groups in order to ensure adherence to ISO standards.

+ Creating problem reports for nonconforming raw material

+ Ensuring discrepancies are thoroughly identified, defined, and properly assessed.

+ Interacting with interdepartmental contacts on change and discrepancy assessment, resolution, and quality approval.

+ Providing timely information to Operation.

+ Update and meet metrics

+ Identifying opportunities for continuous improvement of the Quality Systems and participate in implementation.

+ Maintain calibrated tools and equipment

+ Be able to communicate technical issues and inspection results orally and in writing.

+ Ability to work independently and as part of the QA Team

+ Sense of urgency with completion of projects and tasks

+ Serves as a backup for other Quality positions as needed


**How will you get here?**


+ Bachelor degree in Chemistry or Life Sciences


+ 2-5 years Analytical Laboratory experience in the Pharmaceutical or Biotechnology industry desired. Working knowledge of common analytical technique is preferred


**Knowledge, Skills, Abilities**


+ Attention to details, desire to be hands-on, and excellent bench work management.

+ Experience with Agile and Track-Wise is preferred

+ Proficient in data analysis and a working knowledge of SAP and excel is a plus.

+ The candidate must have solid technical writing, interpersonal, and communication skills and be a team player.

+ Knowledge of International Standards ISO-9001, ISO-13485, and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR) is a plus

+ Works 50 % in an office environment and 50 % in a laboratory environments


**APPLY NOW!**


**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com**


**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. 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-02-12 Expires: 2021-03-18

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QA Engineer-Analytical experience

Kelly Services
Austin, TX 78703

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