Quality Assurance Specialist

Job Title

Field Specialist – QA Operations

Devens, MA 01434

$57.84/hr on W2

• 5am – 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.

Contractor Field QA Specialist for the LSCC in Devens, MA. Responsible for quality activities for the LSCC in accordance with client 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.
• Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Recognize and resolve quality issues; inform management of proposed solutions.

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

• Action‑oriented with strong decision‑making, problem‑solving, and analytical thinking skills.
• Excellent written and verbal communication; ability to prepare written communications and communicate problems to management with clarity and accuracy.
• Strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles.
• Knowledge of FDA regulated cGMP warehousing, quality, and compliance environments; preferred knowledge of GMP manufacturing operations and processes.
• Understand continuous improvement and improve efficiency and productivity within the group or project.
• Build relationships internally within and with cross‑functional teams.
• Ability to develop and revise procedures; intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Contract role; benefits beyond compensation not specified.