Field QA Operations Specialist

Job Title
:
Field QA Operations Specialist

Location
:
Devens, MA

Duration
:
Contract

Contractor Work Model
:
Onsite

Work Schedule
: 2 week rotation

• 5am to 5:30pm, 2 on (Tue, Wed)
• 2 off (Thurs, Fri)
• 3 on (Sat, Sun Mon)
• 2 off (Tues, Wed)
• 2 on (Thurs, Fri)
• 3 off (Sat, Sun, Mon)
• Holidays included as the needs of the business warrant.

We are seeking a Field QA Specialist for the QA Operations organization. The Field QA Specialist is responsible for quality activities for the LSCC in accordance with COMPANY policies, standards, procedures, and Global cGMP.

• 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.

• Associate's or Bachelor's degree required.
• Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
• 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. 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.
• Develops and revises procedures.
• 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.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
• Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.

System One, and its subsidiaries including Joulé, ALTA IT Services, 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.

: #558-Scientific