Principal Quality Assurance Validation Specialist

Job Post Index 262F72-Sy##
Location Devens, MA
Description: Description
  • Role will support the validation of computerized systems, including, but not limited to, process automation systems (DeltaV), manufacturing execution systems (MES), databases, Analytical Equipment, and IT infrastructure.
  • Oversee the qualification of process automation systems, Analytical and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
  • Interface with MS&T, Validation, and end user groups as a Quality 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.
  • Support the implementation and maintenance of Computer System changes, aligning with site compliance policies and procedures.
  • Review and approve 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.
  • Review and approve exceptions associated with the qualification and participate in resulting investigations and correction / corrective action planning.
  • Verify compliance with applicable Policies, Guidelines and Directives and ensures consistency with site procedures and/or specifications.
Skills: Qualifications
  • Knowledge of science generally attained through studies resulting in a Bachelor’s Degree in a scientific or engineering discipline.
  • A minimum of 6 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: Veeva Vault is desirable
  • Effective written and verbal communication skills Development Value
  • Must have computer system validation w/a quality compliance mindset.
  • Proactive, self-motivated and needing minimum supervision
  • Deviations and investigations expertise
  • MES systems preferred
  • $81-$82/hr
  • Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
  • Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
  • Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
  • 401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
  • Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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