Senior Quality Assurance Associate

About the Role

This position is a vital Plant Quality Assurance (PQA) role on the floor, supporting Manufacturing activities. You will work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. The majority of your shift will be spent in clean room space, including gowning in and out of frocks and coveralls.

Responsibilities

• Provide Quality oversight to ensure operations, products, facilities, equipment, materials, organization, processes, procedures, and products adhere to current applicable regulations, including cGMP practices.
• Perform review and approval of cGMP processes, procedures, documents, and records.
• Review logbooks, batch records, attachments, work orders, and other GMP documentation.
• Ensure deviations from established procedures are documented per procedures.
• Verify that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alert management of quality, compliance, supply, and safety risks.
• Complete required assigned training to permit execution of tasks.
• Communicate and collaborate with the PQA shift to ensure required tasks are completed.

Qualifications

• Bachelor’s degree and 2 years of Quality/Manufacturing work experience (preferred).
• Experience working in a cGMP environment.
• Experience with decision-making, analytical testing, and/or general compendia testing.
• Experience working with batch records and other GMP documentation.
• Knowledge of data integrity requirements.
• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams).
• Experience collaborating within and across functional areas with a demonstrated customer service focus.
• Excellent written and verbal communication skills.
• Ability to prioritize and navigate ambiguity with minimal oversight in a fast-paced environment.

Pay

Target PR range: $19–$27 per hour, depending on experience.