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Quality Assurance Specialist

2 months ago

Reston, Virginia, United States SSi People Full time

Job Title: Field Quality Assurance Specialist

Location: Devens, MA

Duration: 12+ months

Pay Rate: $55-60/hr on W2

Work Schedule: Mon - Fri, 2:00 PM - 10:30 PM EST

Job Summary

  • SSi People is seeking a skilled Field Quality Assurance Specialist to join our team at the Single Use Facility in Devens, MA. The successful candidate will be responsible for ensuring quality activities are conducted in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
  • The Field Quality Assurance Specialist will work closely with operations to ensure manufacturing compliance with applicable procedures and batch records, providing real-time review of manufacturing batch record documentation and logbooks.

Key Responsibilities

  • Perform quality assurance activities on the shop floor.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Conduct real-time review of manufacturing batch records.
  • Review manufacturing documentation and logbooks.

Requirements

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

Preferred Qualifications

  • Equivalent combination of education and experience acceptable.
  • Must be action-oriented and skilled in decision-making, building relationships, problem-solving, conflict management, planning, and organizing.
  • 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.
  • Preferably has 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.
  • 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.