QA Manufacturing Specialist II/Sr

This is a day shift opportunity that follows a 2-2-3 schedule.

About the role

The QA Manufacturing Specialist is responsible for ensuring raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position provides a broad range of quality oversight for activities supporting bulk drug substance manufacturing, including shop floor coverage and real-time review of executed records (batch record section review, solution records, equipment records, and logbooks). The role also supports client and regulatory audit/inspection activities.

Responsibilities

• Perform on-the-floor compliance review of executed records, including batch records, equipment preparation records, solution records, associated forms, in-process data, and logbooks.
• Conduct manufacturing walk-throughs, facility responses, and label reconciliation.
• Support the Manufacturing changeover process.
• Collaborate with manufacturing, laboratory, and other GMP departments to resolve deviations, CAPAs, and compliance issues in a timely manner.
• Support client audits, regulatory inspections, and client batch record review processes.
• Assist the QA Raw Material group with the release of raw materials.
• Review document revisions (SOPs, forms, solution records, etc.).
• Support training of other Quality department staff as needed.
• Contribute to process improvement projects, including reducing batch record review cycle times and improving batch release dates.
• Adapt to change productively and handle other essential tasks as assigned.

Requirements

• MQA Specialist II: BS/BA in a scientific field and 5 years of experience, or MS/MA and 3 years of experience in a QA GMP-regulated environment within biopharmaceuticals or equivalent.
• MQA Senior Specialist: BS/BA in a scientific field and 8 years of experience, or MS/MA and 6 years of experience in a QA GMP-regulated environment within biopharmaceuticals or equivalent.
• Knowledge of US and EU cGMP guidelines/regulations is desired.
• Experience with electronic document management systems, SAP, and Microsoft Office suite is preferred.
• Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem-resolution skills.
• Knowledge of biopharmaceutical manufacturing, including cell culture, protein purification, and single-use platform technology, is preferred.