Field QA Specialist cGMP Manufacturing Operations (Onsite, Devens, MA)

We are seeking a Field QA Specialist for a global pharmaceutical company. Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with client 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.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Devens, MA. Work Schedule will be from Mon - Fri, 07:00 AM - 03:30 PM EST.

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 GMP and regulated environment Knowledge of Global and US cGMP requirements

• Experience with Quality processes: CAPA, Deviations, Non-conformance.

• 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

• Must have strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles.

• 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.

• Able to recognize conflict and notify management with proposed recommendations for resolution. Develops and revises procedures.

• High School Degree required Relevant college or university degree preferred.

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