Quality Assurance Senior Specialist-Remote

The Quality Sr. Specialist will be responsible for supporting the Quality Assurance department with review and approval of documents and records. Core responsibilities will relate to batch disposition and supporting the execution and phase-appropriate improvement of the team. This role will be about 20-30 hours a week. Day to day tasks: Batch Review and Disposition Review/approve batch documentation prior to and after execution Batch records, deviations, change controls, test results, etc. Coordinate with cross functional groups to complete batch disposition activities for starting materials, drug substance, drug product, and finished drug product. Resolve issues related to disposition. Actively monitor and manage training, quality event, and change control records to support timely completion of workflow activities by functional and quality assurance personnel. Support Quality and Supply Chain personnel with clinical drug product shipment, material transfer, and inventory management activities as necessary. Support Qualified Person (QP) and Authorized Person (AP) certification of product for geographies where necessary. Document archival in the eQMS system. Quality System Execution and Improvement Author, review, and approve documents. Author change control records where necessary. Initiate and manage document approvals in ZenQMS (the electronic quality management system) or Docusign. Assist with review/execution of internal quality events such as CAPAs, Change controls, and Deviations. Participate in internal/external cross functional meetings as required, and provide aid with risk mitigation activities or path-forward discussions. Assist with other tasks as needed such as complaint investigation review/approval, internal audits/assessments, FDA response coordination, Gap Analysis, regulatory inspection readiness, etc. Help with continuous improvement actions within the Quality Assurance department. Support reporting of Quality metrics as necessary. List above may not be comprehensive of all required activities. Additional duties may be assigned from time to time based on company or departmental needs. Work with cross functional teams to manage deliverables and timelines with minimal oversight. Education: Bachelor’s degree preferred, but experience can substitute for education. Minimum of 5 years working experience in quality assurance department in the biotech or pharmaceutical industry with experience in batch disposition. Preference for direct experience with QP/AP certification. Strong understanding of good manufacturing practice (GMP) requirements. Direct experience working with an electronic quality management system. Preference for ZenQMS experience. Strong project management and organizational skills. Experience in working with contract manufacturers and test labs is preferable. Excellent analytical, problem-solving, and decision-making skills. Job Type:

Part-time Pay:

$48.00 - $55.00 per hour Expected hours:

30 per week Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance Schedule: Monday to Friday Work Location:

In person

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