USA - Quality Assurance Specialist II

  • location: Cambridge, MA
  • type: Contract
  • salary: $55 - $64 per hour
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job description

USA - Quality Assurance Specialist II

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Cambridge, Massachusetts
job type: Contract
salary: $55 - 64 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Under the direction of the Head, Data Systems, R&D Quality Assurance and Compliance, this role is responsible for providing support in the QA oversight of Computerized Systems Validation activities related to systems utilized by R&D. The role of CSQA lead provides compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices. This is accomplished by

  • Provides professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.
  • Participating in the delivery of system solutions by overseeing/reviewing SDLC/CSV/Qualification activities.
  • Guiding development of validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s).
  • Overseeing execution of validation/qualification/verification/migration strategies per company procedure(s).
  • Providing validation/verification/qualification guidance to stake holders as necessary.
  • Managing relationships with key customers and stake holders to ensure oversight that the total validated/verified/qualified solution delivered meets/exceeds expectations.
  • Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner.
  • Subject Matter Expert on company's SDLC/Qualification procedures and regulations and able to provide guidance to IT and/or Business.
  • Participate on cross functional teams to oversee validation/verification, implementation, and maintain regulated (Example: GxP, JSOX etc.) systems across the company.
  • Oversee the validation/verification/qualification strategy development by working with the validation team.
  • Work with project teams offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
  • Ensure the project testing scope is met per specified agreement and/or scope change.
  • Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
  • Thoroughly understands the difference between Positive versus Negative Testing.
  • Insure all SDLC deliverables are completed and stored appropriately.
  • Leads resolution efforts when issues are identified and escalate appropriately.
  • Actively share emerging industry standards/trends with customers and peers within area of responsibility.
  • Guide the response and remediation of corrective actions and internal audits.
  • Cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks.
  • Proactively identify and assist in prioritizing opportunities to streamline validation and or qualification efforts but still stay compliant.
 
qualifications:
  • Bachelors degree in a life science or computer science required; Masters degree in management or scientific discipline a plus.
  • At least 10 years of pharmaceutical experience.
  • Broad experience in computer system life cycle development/computer system validation in R&D.
  • Demonstrated experience leading cross functional teams advising on compliance related matters and influencing Senior Leaders.
  • Access to transportation to attend meetings.
  • Ability to fly to meetings regionally and globally, if needed.
LICENSES/CERTIFICATIONS:

Desired:

  • American Society for Quality (ASQ)

    • Certified Software Quality Engineer (CSQE)
  • Quality Assurance Institute (QAI)

    • Certified Software Test Engineer (CSTE)
 
skills: Quality Assurance, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), SDLC
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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