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Senior Quality Engineer

Kelly Services


Location:
Cambridge, MA
Date:
04/23/2018
2018-04-232018-05-22
Job Code:
US588YAR_BH1435431
Categories:
  • Engineering
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Job Details

Job Title Senior Quality Engineer

Jobid US588YAR_BH1435431

Location: Cambridge, MA, 02238, USA

Description **JOB SUMMARY/OBJECTIVE:**

The **Quality Engineer** is an associate with high level of expertise and experience with general **biopharmaceutical manufacturing equipment, principles and processes** and has a strong understanding of current GXPs, safety, and regulatory standards. The QE will work closely with QC to provide support for **Validation, Maintenance, Engineering, Automation, Metrology, Manufacturing Sciences, Lab operations, and QA Compliance teams** . The QE collaborates with subject matter experts and technical specialists to provide Quality oversight for operation of a cGMP compliant Manufacturing facility and QC Lab Operations with quality assurance needs as defined by departmental management. The QE will be responsible for providing QA support in facility, utility, equipment, and QC Analytical Instrumentation activities for company’s sites primarily located at Cambridge and Lexington MA, and as needed Alachua FL. Activities include **validation, change control, equipment maintenance, automation, and QA capital projects .**


**_Percentage of Time Spent_**


**_Job Function (In order of %)_**


1)


30%


Validation Activities:

Quality lead for QC analytical instrument and equipment validation. Provide quality oversight, review and approval of validation deliverables including validation plans, user requirements, executed test scripts/reports, and associated deviations to assure compliance with corporate standards, practices, and industry requirements. Oversee the change-control aspects of validation, ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing are adequate and well justified. Provide quality oversight of the QC equipment and instruments maintenance, calibration, and periodic assessment. Report and trend performance metrics for validation projects, including metrics for change control.


2)


30%


Change control:

Subject Matter Expert responsible for maintaining change control system. Provides QA support on change controls. Leads and manages change control proposal meetings. Reviews for execution approval of change controls per change control SOP and client agreements. Performs final review and approval of change controls.


3)


15%


Exceptions:

Provide QA support, and guidance on exceptions related to facility, utility, equipment, process, and QC lab operation activities.


4)


15%


Subject Matter Expert for Changeover Program. Performs QA changeover requirements and maintains documentation.


5)


10%


Support QA Compliance activities as needed. Support regulatory and client audits as required.

**POSITION REQUIREMENTS:**


+ **Must have strong knowledge of 21 CFR, ICH, and EU regulations**
+ Must possess strong knowledge of **QbD, Risk Based approach, and performing Risk Assessments**
+ Must be skilled in the use of a personal computers and related software applications.
+ Must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
+ Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
+ Must be proficient at public speaking, teaching, facilitating to peers, senior associates, and area management within their operational group.
+ Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.
+ Must be able to understand operational documents for **GMP** compliance, accuracy and completeness.
**EDUCATION AND QUALIFICATIONS:**


+ **Bachelor’s Degree in Sciences or Engineering**
+ **Minimum 5+ years industry related experience**
+ Strong interpersonal and communications skills; written and oral
+ Solid understanding of applicable regulatory requirements
**Why Kelly** **®** **?**


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

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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