Senior QA Associate

The Role

The Senior QA Associate will serve as a key Quality Systems subject matter expert (SME), supporting multiple core elements of the site Quality Management System (QMS), including deviations, investigations, CAPAs, change controls, complaints, document control, and quality event trending. This role acts as a cross-functional QA partner to Manufacturing, Packaging, QC, and Engineering, ensuring that all quality records are accurate, compliant, and scientifically justified.

Responsibilities

• Review, approve, and manage deviations, investigations, CAPAs, change controls, and complaint records to ensure compliance with cGMP and data integrity expectations.
• Conduct structured root cause analyses and develop scientifically justified corrective and preventive actions.
• Author, revise, and review controlled documents, including SOPs, batch records, protocols, reports, and risk assessments.
• Perform trend analysis of key quality metrics to identify systemic issues and support continuous improvement initiatives.
• Provide QA support during internal audits, customer audits, and FDA inspections by preparing documentation and offering subject matter expertise.
• Collaborate across operations to resolve documentation issues and ensure compliant execution of quality-related activities.
• Support training efforts by assisting in the development and communication of investigation-writing and QMS best practices.

Requirements

• Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Pharmaceutical Sciences, or Engineering.
• 5–8 years of pharmaceutical QA experience, preferably within oral solid dosage manufacturing.
• Strong expertise in deviation investigations, CAPA management, change controls, and technical documentation.
• Advanced knowledge of cGMP, data integrity principles, and ICH guidelines.
• Proficiency with electronic QMS platforms (such as MasterControl, TrackWise, or Veeva) and strong analytical and communication skills.

Qualifications

• Experience with electronic QMS platforms (such as MasterControl, TrackWise, or Veeva).
• Strong analytical and communication skills.

Skills

• Strong technical writing skills.
• Expertise in QMS processes.
• Ability to lead complex investigations and support audits and inspections.
• Knowledge of cGMP, data integrity principles, and ICH guidelines.

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays