Quality Operations Specialist

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 Skills : QA Operations GMP Documentation