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Quality Assurance Engineer

Quality Assurance Engineer ? Alachua, FL
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Kelly Scientific is seeking a Quality Engineer for a biologic manufacturing company in the Gainesville, FL. This is a direct hire opportunity. Monday-Friday on the 1st shift.
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Ideal candidates will have strong experience with Investigations and CAPA?s. Pharmaceutical and Biologic manufacturing experience will be considered.????????
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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 and provide support to the Validation, Maintenance, Engineering, Automation, Metrology, Manufacturing Sciences, Lab operations, and QA Compliance teams.? A QE collaborates with subject matter experts and technical specialists to provide Quality oversight for operation of a cGMP compliant Manufacturing facility with quality assurance needs as defined by departmental management. ?The QE will be responsible for providing QA support in facility, utility, equipment, and construction GxP activities for Company sites primarily located at Alachua, FL.? Activities include validation, change control, equipment maintenance, automation, and QA capital projects.?
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ESSENTIAL JOB FUNCTIONS:


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Percentage of Time Spent


Job Function (In order of %)


1)


40%


Validation Activities:


Provides QA support in validation strategy meetings related to facility, utility, automation, equipment and QC Lab operation activities.


Provides QA support for process validation activities. Provide comments for proposed protocols. Performs initial and final review of protocols. Reviews and approves protocol deviations.


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)


20%


Exceptions:


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


4)


10%


Support QA Compliance activities as needed or assigned by the Alachua Quality Director.? Support regulatory and client audits as required.


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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.?



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EDUCATION AND QUALIFICATIONS:
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  • Bachelor?s Degree in Sciences or Education


  • Minimum 5 years? industry related experience with a Bachelor?s Degree


  • Strong interpersonal and communications skills; written and oral


  • Solid understanding of applicable regulatory requirements



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PHYSICAL DEMANDS/FACTORS:
While performing the duties of this job, the employee:




  • Ability to function in a dynamic environment and balance multiple priorities simultaneously.


  • Ability to learn new software and tools quickly.


  • Ability to make decisions and work with minimal to moderate supervision.


  • Ability to aseptically gown and/or sterile gown as needed.


  • While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time.? Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.


  • Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.



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Note: This job description is not all-inclusive.? Additional duties may be performed, as assigned.? It acts as a guideline and is subject to change over time.



Why Kelly??

With Kelly, you?ll have access to some of the world?s highest-regarded scientific organizations?
providing you with opportunities to work on today?s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you?ll be proud to help
advance. We work with 95 of the Fortune 100? companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career?connect with us today.



About
Kelly 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 is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


 

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