QA Operations Specialist

Quality Operations Specialist - Hybrid

The Quality Specialist provides direct Quality support to a production areaas part of a Quality IPT (Integrated Product Team).With guidance from theAssociate Directorof Quality Operations,the Quality Specialistensures 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:

• Performsreviewof processdocumentation/datafor accuracy,completeness,anddata integritycompliance.Responsible forreview/approvalof new and updated Master Batch Records/ Electronic Batch Records
• Review and approve production documentation such as executed electronic batch recordsandlogbooksto ensure accuracy and compliance withcGMPsand 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 5years of relevant post-degree work experience inGMP Manufacturing, Quality Assuranceor 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