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21 days old

Quality Engineer

Kelly Services
Allentown, PA 18103
**JOB TITLE: Quality Engineer**


**WORK LOCATION:** Allentown, PA


**DURATION:** 3 Months (Temporary / Contract)


**PAY RATE:** $35 an hour W2


**JOB** **_DESCRIPTION:_**


**What will you do?**


Our company is seeking a Quality Engineer responsible for quality approval for equipment validations (IQ,OQ,PQ), risk assessments (FMEA), alarm management (temperature, humidity, differential pressure), and oversite of Maximo work order system (calibration, corrective maintenance).This role requires the ability to make decisions that are based on sound quality/compliance principles and appropriate GMP Regulations.


**Education**


+ Bachelors Degree.


**Responsibilities**


+ Apply Good Manufacturing Principles in all areas of responsibility.

+ Demonstrate and promotes the company vision.

+ Review impact analysis of changes to facilities and equipment.


+ Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.

+ Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).

+ Drives continuous improvement to the sites equipment and facilities qualification/validation program.

+ Assist in the review of site procedures related to equipment and facilities as required

+ Monitor the sites calibration program.

+ Monitor the sites preventative maintenance program.

+ Facilitate, participate, and approve Risk Assessment.

+ Conduct all activities in a safe and efficient manner.

+ Other duties may be assigned to meet business/compliance needs.


**Knowledge, Skills, Abilities**


+ A minimum of 5 years in the pharmaceutical/related regulated industry.

+ Experience with equipment and facilities validation Quality Systems.

+ Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.

+ Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.

+ Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.

+ Good written and verbal communication skills.

+ Thorough understanding of regulatory documentation requirements.

+ Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.

+ Ability to work independently.

+ Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems.

+ Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

+ Experience in Risk Assessment.


**Physical Requirements**


+ This position is administrative and is positioned in an office environment but does require some time in manufacturing, packaging, and computer areas.

+ It requires standing bending reaching, walking and talking as well as exerting up to 20lbs.


**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.


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*


**Let us help advance your career 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: 2021-04-02 Expires: 2021-05-03

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Quality Engineer

Kelly Services
Allentown, PA 18103

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