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12 days old

QUALITY ASSURANCE ENGINEER

Kelly Services
Warren, NJ 07059
**BH - 3061203**



***** MUST BE ABLE TO WORK ON A W/2 BASIS** **_(without Sponsorship)_** ***** NO C2C *** REMOTE BLEND*****



*****NOTE*** If your experience is not in this area of specialty, please refrain from sending your resume.**



**_Our Client located in WARREN, NEW JERSEY is expanding and currently seeks a_**



**QUALITY ASSURANCE ENGINEER**


**_for a 6+ MONTH assignment with possible extensions!!_**



**Leverage your GMP and SOFTWARE VALIDATION experience**



**to take your CAREER to**



**the "Next Level" for** **_2020 and beyond!_**





**POSITION SUMMARY:**

The Quality Assurance Engineers primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. Altogether, the Contractor will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of company products.


**REQUIRED SKILLS:**


Advanced knowledge of GMP guidance and regulations, including those pertaining to

computerized system design, function, and use. ***Ideally, candidates with IT background in software validation & quality experience.***

**Intermediate knowledge of Delta V, OSI Pi, LIMS (HIGHLY PREFERRED)**



Advanced knowledge of electronic batch records, Microsoft Word, Outlook, and Excel.

Requires ability to communicate appropriately with regulatory agencies.

Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles

Intermediate problem-solving, critical-reasoning, and decision-making skills.

Intermediate time-management, organizational, and multi-tasking abilities.

Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.

Ability to interpret / write technical documents.

Ability to solve routine and complex problems.

Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.


**Education and Experience:** Bachelor of Science degree required, with a minimum of 7 years of related Quality, Manufacturing, and Compliance experience in the pharmaceutical industry.


**RESPONSIBILITIES:**

Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.

Drives use of best-practices during IT systems design, validation, and use.

Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.

Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.

Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes, but not limited to functional requirements, user requirements, and design specifications.

Reviews and approves documents, change controls, and protocols related to IT systems.

Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.

Supports deviations as needed.

Represents and leads Quality Assurance Operations for through the initiation and implementation of projects related to electronic systems.

Manages project activities and ensures appropriate team members are assigned to appropriate activities.

Supports continual alignment of the business process with other business functions and provide effective on-going end user support.

Develops, maintains and improves key business processes.

Provide training to appropriate end users as related to enterprise system implementation and updates.

Drafts, reviews, and edits SOPs, process flow and other business documentation.





**Important Information:**



**There is no per Diem with this position**



**There is no relocation budgeted for this position. If this position requires you** **to relocate you will be responsible for those costs.**



**MUST be able to work without sponsorship or VISA transfer for this position**






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



By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.





**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.
Posted: 2020-09-07 Expires: 2020-10-08

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QUALITY ASSURANCE ENGINEER

Kelly Services
Warren, NJ 07059

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