Quality Assurance Specialist I-IV

About the role

This individual will support clinical manufacturing operations. This individual will provide oversight of manufacturing activities from a quality perspective with limited supervision.

Responsibilities

• Oversight (with limited supervision) of clinical manufacturing activities (phase 1, phase 2 of APIs, ADCs), including area clearance, issuance, and review of batch records, and making decisions on initiation of deviations and investigations.
• Oversight (with limited supervision), review, and approval of Materials Management and supply activities.
• Revision and/or review and approval of SOPs, Protocols, Reports, and Batch Records for continuous improvement.
• Support of Environmental Monitoring Program including Controlled Environments and Clean Utilities.
• Initiation of Discrepancies, including Deviations and Investigations
• Support of implementation of CAPA as determined.
• Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods.
• Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
• Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
• Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators.

Requirements

• Perform other job-related functions as needed.
• Able to handle multiple client projects for Quality requirements.
• Strong knowledge of Microsoft Word, Excel, and Power Point.
• Strong written and interpersonal communication skills.
• Ability to write and present reports/investigations and host meetings to support Quality Systems
• Ability to train employees in a small group setting.
• The ability to work independently and as part of a team.

Qualifications

• Bachelor Science degree in Chemistry/Biology or related discipline
• 0-5 years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience or in GMP environment.

Skills

• Working knowledge of GMPs and their application to biotech/pharma/phase 1 and 2 clinical manufacturing
• Strong compliance knowledge of GMP Quality Systems, policies, and regulations
• Must be able to interpret applicable GMP standards and objectively decide on items with management support.

Pay

TBD

Schedule

Full-time and on-site