Field QA Specialist

Devens, Massachusetts
March 24, 2025
$57 / hour
Contract
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Job Description

Job Summary:

  • Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the client in Devens, MA.
  • The Contractor Field QA Specialist is responsible for quality activities for the client in accordance with Client policies, standards, procedures, and Global cGMP.

Responsibilities:

  • Perform QA on the floor activities.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Perform real time review of manufacturing batch records.
  • Review manufacturing shop floor documentation.

Education and Experience:

  • Relevant college or university degree required.
  • Minimum 4 years relevant work experience, with experience in a Quality Assurance role.

Knowledge, Skills and Experience Required:

  • Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Builds relationships internally within and with cross functional teams.
  • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
  • Prefer to also have knowledge of GMP Manufacturing operations and processes.
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
  • Seeks management guidance on complex issues.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Must possess an independent mindset.
  • Work is self-directed.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Confident in making decisions for non-routine issues.
  • Develops and revises procedures.
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
  • Able to effectively multi-task.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.

Schedule Note (Work Schedule is a 2 week rotation as detailed here):

  • 5:00am- 5:30pm: 2 days on (Tuesday, Wednesday);  2 days off (Thursday, Friday); 3 days on (Saturday, Sunday, Monday); 2 days off (Tuesday, Wednesday); 2 days on (Thursday, Friday); 3 days off (Saturday, Sunday, Monday).

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