Senior Associate, Plant Quality Assurance

This Senior Associate PQA position is the primary QA resource during manufacturing production activities, providing real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities. This position will be required to proactively support cGMP compliance and interact with all departments within the company.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

Key responsibilities:

Ensure quality and regulatory compliance during on-the-floor processing.

Work alongside manufacturing teams to ensure current and best practices are implemented consistently maintaining compliance with cGMP standards and keeping the plant in compliance with corporate quality requirements.

Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment.

Review and approve deviations, CAPAs, and change controls

Review and approve executed production batch records, logbooks, data, and Certificates of Analyses.

Perform verification of data to assist with batch disposition process.

Review and approve quality documents from Manufacturing, QC, Facilities & Engineering, Validation and PD, such as: SOPs, batch records, logs, training forms, protocols, plans, summary reports, risk assessments, work orders, etc.

Conduct training on procedures, standard work, safety, and cGMP related topics

Assist internal and external audits and regulatory inspections

Other responsibilities:

Proactively support cGMP compliance in the business by reporting on KPI performance

Assist with the implementation and continuous improvement of the Quality System

Support Clinical QA activities as needed

Assist with vendor qualification or evaluation/inspection.

Lead and participate in continuous improvements

Other duties, as assigned

Qualifications

Educational requirements:

Bachelor's degree in science preferrred

Experience and skill requirement:

3-5 years of quality or mix of quality/manufacturing experience in biotech or pharmaceutical industry.

High level of attention to detail and excellent time management.

A very organized and methodical approach to tasks.

Strong written and verbal communication skills to interact with other functions

Strong collaboration skills

Location:

This position is based in our Framinghamlocation and typically has a 5-day on-site expectation.

Regular Full-Time