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15 days old

Quality Engineer

Kelly Services
Coppell, TX 75099
**Job Details:**


**Industry:** Biopharmaceutical


**Work Location:** Coppell, TX


**Job Title:** Quality Engineer


**Duration:** 6 Months (Temporary/Contract)


**JOB DESCRIPTION:**

Candidate should be local to Coppell TX, and able to come on site, as needed.


The Quality Assurance Engineer provides general support in the development and maintenance of the Quality Management System within a facility manufacturing Active Pharmaceutical Ingredients. This hands-on QA/QE role is focused on supporting Operations personnel in the manufacturing facility and facilitating compliance with site procedures and applicable regulations. Acting as as custodian for various quality systems/process (Deviation, CAPA, Complaints, Change Control), writing Standard Operating Procedures, conducting and documenting investigations, and supporting site functions such as Facilities and Engineering, Validations, Automation by reviewing protocols, and other technical documents.


**Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)**

**Key Accountabilities:**


Escalates quality issues to Site Quality Leadership Team, and product Qualified Person of critical deviation or complaints that may impact the product disposition or product in-market.

Report to QA management potential issues of non-compliance.

Ethical conduct and compliance Provide Process/Quality Engineering support to site overseeing manufacturing, facilities and engineering operations, helping to ensure delivery of highest quality product to the customer. Develop, implement and maintain Quality Assurance processes and systems.

Act as custodian for various Quality Assurance processes (Quality Investigation, CAPA, Internal Audit, Change Control, etc.) as assigned.

Write, edit, and review Standard Operating Procedures and various Quality related technical documents (protocols, specification, work instructions, batch records, etc.) in a highly collaborative environment.

Conduct or supports quality investigations (Deviation, CAPA, etc.) and document in

appropriate reporting methods and systems.

Participate in internal Quality System / cGMP audits.

Participate and act as subject matter expert during internal and corporate audit, and external inspections.

Proactively look and implement simplification and compliance improvement activities to drive a mature quality culture at the site

Conduct walkthroughs and go to the Genba to support site functions to improve their

inspection readiness agenda.

Other responsibilities as assigned by department management


**Essential Desirable**

Bachelors degree in Science, Pharmacy, or Engineering

A minimum of 3 to 5 years of experience as a Quality Assurance professional in the pharmaceutical manufacturing industry (finished drug product or Active Pharmaceutical Ingredients / complex chemical processing of excipients).

Knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing; experience with regulatory agency interactions

Must be able to demonstrate proficiency in verbal and written communication in English.

Must be familiar with and competent in the use of Microsoft Word, Excel, and PowerPoint.

Must be willing to address emergent factory quality and compliance issues by being available via telephone during off hours.


**Why Kelly?**

As a Kelly Services employee, you will have access to numerous perks, including:


+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*


**Apply Today!**



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


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-10-01 Expires: 2021-11-01

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Quality Engineer

Kelly Services
Coppell, TX 75099

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