Field QA Specialist Pharma (Onsite Devens, MA)

We are seeking a Field QA Specialist Pharma (Onsite Devens, MA) for a global pharmaceutical company. You will be responsible for quality activities for the LSCC in accordance with client's, standards, procedures, and Global cGMP.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Devens, MA.

Work Schedule is a 2-week rotation as detailed here: * 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)

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities:

• 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.
  

Requirements:

• Minimum 4 years relevant work experience, with experience in a Quality Assurance role.

• Experience in FDA-regulated cGMP warehousing, Quality, and compliance environments.

• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

• 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.

• Knowledge of GMP Manufacturing operations and processes is preferred.

Please submit your resume to our network at (please apply to the Field QA Specialist Pharma (Onsite Devens, MA) role).