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PDS Tech Inc Quality Specialist II in Cambridge, Massachusetts

PDS Tech is seeking candidates for a Quality Specialist II position in Cambridge, MA.

How will you make an impact?

The Quality Assurance Specialist II will support the quality systems team in Cambridge, MA. The Specialist will be responsible for evaluating, reviewing, and approving CAPAs or Change Controls. In this role, they will support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems.

What will you do?

  • Conduct QA assessments of product specific change controls, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision maker

  • Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations

  • Work with functional groups across the site to review and approve quality and technical documentation including: CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation.

  • Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities

  • May perform archiving duties in support of QA Document Control

  • Will perform data migration from paper systems to new electronic data systems.

How will you get here?

Education, Experience

  • Bachelor's degree and 3 years of related work experience or Master’s degree and 1 year of work experience.

  • Preferred experience working in 2 or more functional areas

  • Minimum of 2 years in cGMP Quality Control operations in a fast-paced production environment

Knowledge, Skills, Abilities

  • Demonstrated ability collaborate across the business.

  • Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.

  • Demonstrated ability to present ideas persuasively and negotiate effectively

  • Excellent written and oral communication skills both internal and external.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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