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Quality Assurance Specialist

System One

Responsibilities
Benefits
Special Commitments

Job Title: Quality Assurance Specialist

Location: Devens, MA/ Hybrid

Type: Contract

Overview

Global Pharma company looking to hire entry to mid level Quality professionals! BS Degree is required. 

Responsibilities

  • Prepares documentation and deliverables per Standard Operating Procedures required for drug product disposition.
  • Works in electronic systems such as SAP, Learning Management, and Document Management systems.
  • Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.
  • Perform the review of batch genealogy for all raw materials and components used in each batch to ensure that they are approved and released.
  • Works in electronic systems such as SAP, Learning Management, and Document Management systems.
  • Works on assignments of simple to moderate complexity where some judgment is required in resolving problems and making routine recommendations.
  • May contribute to drafting, reviewing, or approving procedural documents.
  • Other duties as required.

Requirements

  • B.S., in science, engineering, biochemistry, related discipline, or its equivalent
  • 0-2 years of directly relevant experience in a regulated cGMP environment.
  • Any combination of education, experience, and military service in line with recommendations above will be considered.
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
  • Previous work/academic experience where attention to detail and personal accountability were critical to success.
  • Strong communication skills and the ability to follow written and verbal instructions.
  • Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
  • Knowledge of electronic systems including any of the following preferred: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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