Quality Assurance Specialist/ Manager
Quality Assurance Specialist 2004772
Location: Greater Boston, MA (Onsite)
Science/ Focus: Biologics
Job Overview: Our client is looking to add a QA Specialist to their growing team to support and expand on the quality management systems and processes including GCP and GLP activities
- Maintain Quality systems including CAPA, deviation, risk analysis and change control management.
- Perform inspections and internal audits and participate in audit preparation for GLP, GCLP
- Participate in audits from external partners and regulatory agencies
- Create, revise, and review SOP’s, Training and work instructions
- Oversee qualification of equipment, systems, and suppliers
- BS with 3+ years in biopharma Quality Assurance (experience within GLP or GCP preferred)
- Strong experience in Quality Systems- CAPA, deviation, risk analysis and change control management
- Experience working in CLIA/ CAP regulated setting is preferred
- Experience participating in FDA inspections preferred
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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