Quality Assurance Specialist I
Repligen Corporation · Marlborough, MA · 2 wk ago
Quality Assurance$30.24/hrFull-time
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
Benefits
- Paid time off
- Health/dental/vision
- Retail benefits
- Flexible spending accounts
Pay
- $30.24/Hr. - $40.92/Hr.
Schedule
- Full-time