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18 days old

Principal Quality Assurance Validation Specialist

Kelly Services
Devens, MA 01434
**Principal Quality Assurance Validation Specialist, Devens, MA (Primarily remote)**


Kelly Services is seeking a Principal Quality Assurance Validation Specialist, highly experienced computer systems validation professional with strong compliance mindset. Role will oversee the validation of computerized systems, including, but not limited to, process automation systems, manufacturing execution systems (MES), laboratory instruments, databases, and IT infrastructure for one of our top clients in Devens, MA.


**Length:** 7 Months


**Type:** Contract W2There 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. NO C2C, at this time we are not in the position to offer any type of sponsorships or VISA transfers for this position.


**Pay Rate:** $negotiable/hr. (W2)


**Ideal candidate has the following experience:**


+ A minimum of 9 years experience in an environment governed by cGMPs, in a computer systems validation or quality assurance validation role overseeing electronic equipment and computerized systems validation

+ Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.

+ Proficiency in the use of computers and software applications including electronic validation documentation systems (such as ValGenesis and ALM


**Detailed Position Responsibilities**


+ Oversee the qualification of process automation systems, laboratory and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.

+ Interface with Engineering, Validation, and end user groups as a QA subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, software testing, system administration, data management, and risk-management.

+ Oversee the development, implementation, and maintenance of site procedures and policies for Computer System Validation, aligning with global policies and procedures.

+ Review and approve validation plans, qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.

+ Ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.

+ Review and approve exceptions associated with the qualification and startup of the Devens Cell Therapy Facility and participate in resulting investigations and correction / corrective action planning.

+ Verify compliance with applicable company Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.


**Desired Experience**


+ Knowledge of science generally attained through studies resulting in a Bachelors Degree in a scientific or engineering discipline or its equivalent.

+ A minimum of 9 years experience in an environment governed by cGMPs, in a computer systems validation or quality assurance validation role overseeing electronic equipment and computerized systems validation

+ Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.

+ Firm understanding of quality systems

+ Proficiency in the use of computers and software applications including electronic validation documentation systems (such as ValGenesis and ALM)

+ Demonstrated interpersonal, communication, and motivation skills.

+ Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.

+ Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is required

+ Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva Vault is desirable

+ Effective written and verbal communication skills

+ Development Value

+ Gain experience in Cell Therapy start-up and operations

+ Interface with many functional areas including Manufacturing Technology, Digital Plant, Manufacturing, Validation, Quality


**Apply Today!**


**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 (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.

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Posted: 2021-09-29 Expires: 2021-10-30

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Principal Quality Assurance Validation Specialist

Kelly Services
Devens, MA 01434

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