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Field QA Specialist for QA Operation

Devens, MA

Posted: 02/01/2023 Job Number: 23012353

Job Description

2nd shift in a Single Use Facility cGMP
This role is 100% Onsite.
Working Hours - 2PM - 10PM, M F.

Required Skills:
  • High School Degree required, but relevant college or university degree preferred.
  • Minimum 2 years relevant work experience, with experience in a Quality Assurance role .
  • Equivalent combination of education and experience acceptable.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles. Experience with documentation review.
  • Must be action-oriented and skilled/confident 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.
  • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
  • Knowledge of GMP Manufacturing operations and processes is also preferred .
  • Oversees quality initiatives for continuous improvement and enhancement of site quality system efficiencies.
  • Routinely recognizes and resolves quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops and revises procedures.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Must possess an independent mindset as the work is self-directed .
  • Requires moderate direction to complete more complex tasks, completes routine tasks with little or no supervision.
  • 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.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
  • Able to effectively multi-task.

Project Description:
  • Seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA.
  • The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with company policies, standards, procedures, and Global cGMP.
  • Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.
  • 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.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.Com


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Cheryl Ambrose

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