The Quality Assurance Associate II will report directly to the QA Manager or Quality Director.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System.

Must have thorough understanding of Good Documentation Practices (GDP), identification, review, and approval of nonconformance and deviation investigations, able to perform root cause analysis and generate corrective actions to improve processes/systems.

• Assist with the maintenance of the Repligen Quality Management Systems (QMS).
• Generation, review, and approval of quality investigations including nonconformance and deviation investigations.
• Participate in or lead quality meetings with multi-functional departments / individuals.
• Compile and analyze information/data related to nonconformance, deviation, corrective action, root cause, and customer complaint investigations.
• Perform trend analysis of supplier, internal quality issues, customer complaints, NCMRs etc. for monthly KPIs and for Management Review meetings.
• Identify, detect, and escalate quality related trends.
• Support Customer, Suppliers, Internal, and ISO Audits.
• Support completion of Customer Documents / Questionnaires.
• Initiate, manage, and support Change Control, Deviations, Corrective Actions, etc.
• Technical Writing for Standard Operating Procedures (SOP) and Work Instructions (WI).
• Review procedures, protocols, and other technical documents related to Quality.
• Lead QMS & Process Improvements to meet ISO 9001 compliance.

• Bachelor’s degree in Biological Science or other science related discipline.
• Minimum 2-5 years’ experience in QA in an ISO 9001 certified Quality Management System or equivalent.
• Ability to communicate with multiple departments and associates.
• Shares timely information with peers on daily progress.
• Ability to contribute to project teams.
• Focus and attention to detail is critical.
• Lead/Internal auditor certification preferred.
• Experience and knowledge of IT software platforms that support Quality Management Systems.

Physical Requirements:

• Regularly required to sit, stand; walk; use hands to finger in an office environment.
• Occasionally required to reach with hands and arms.
• Able to lift and /or move up to 25 pounds.
• Specific vision abilities required by this job include peripheral vision and depth perception.
• Individual to wear PPE and gowning to work in cleanroom environment.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is USD $26.27/Hr.-USD $32.69/Hr. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.