Negotiable
Quality Operations Specialist - Hybrid
The Quality Specialist provides direct Quality support to a production area-as part of a Quality IPT (Integrated Product Team).-With guidance from the-Associate Director-of Quality Operations,-the Quality Specialist-ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.-
Key Responsibilities:
- Performs-review-of process-documentation/data-for accuracy,-completeness,-and-data integrity-compliance.-Responsible for-review/approval-of new and updated Master Batch Records-/ Electronic Batch Records
- Review and approve production documentation such as executed electronic batch records-and-logbooks-to ensure accuracy and compliance with-cGMPs-and company procedures-
- Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
- Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
- Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
- Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
Qualifications and Experience
- Bachelor degree, in a scientific or engineering field
- Minimum 5-years of relevant post-degree work experience in-GMP Manufacturing, Quality Assurance-or Laboratory environment,-Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
- This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
- Evidence of leadership skills coupled with good oral and written communication skills-
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment