The Quality Assurance Specialist I supports the Tangenx and Dulocore product lines as part of the Quality team at the Marlborough site. This role is responsible for contributing to the effectiveness of the Repligen ISO 9001 Quality Management System (QMS), with primary focus on ensuring the accuracy, completeness, and compliance of production batch record review and product release activities.
In addition, the position supports core Quality processes, including the management of deviations, corrective and preventive actions (CAPAs), nonconformances, and controlled documentation, ensuring adherence to GDP standards and internal procedures.
Bachelors Degree preferred, or equivalent work experience.
This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.
Responsibilities:
- Review batch records, logs, and other documentation to ensure compliance to GDPs and governing SOPs
- Process SAP transactions to accept and release batches
- QA review and approval of QS records (Deviations, CAPA, Change Controls, Risk Assessments, etc.)
- Collaborate with Manufacturing to resolve equipment and process issues
- Author/Revise/Review SOPs, Forms, etc. as Quality SME
- Work with applicable groups towards process improvements
- Support internal and external audits
- Apply Quality Risk Management principles in daily decision-making
- Identify, assess, and escalate quality issues as appropriate
Qualifications:
- Proficient with Microsoft Office (Word, PowerPoint, Excel, Outlook)
- SAP experience
- Effective written and verbal communication skills
- Superior attention to detail, strong organizational skills and the ability to multi-task and work effectively in a highly-collaborative, cross-functional, fast-paced environment
- Experience with good documentation practices and ISO9001 quality management system
- Experience with paper and Electronic Batch Records
- Working knowledge of quality processes including deviations, investigations, change control, material disposition, and CAPA management
- Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence
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 hourly rate/salary range for this role, based in the United States of America is $30.24/Hr. -$40.92/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.
