QA Specialist (1st Shift)

Key Responsibilities

• Execute and develop proficiency in all Level 1, Level 2, and Level 3 Quality Assurance tasks:
• Level 1: Manufacturing / Packaging Line Clearances, Product Label Review and Approval, Product Label Reconciliation, EMS Data Review, Logbook Review and reconciliation
• Level 2: Batch Record Issuance, Batch Record Review and Approval, Incoming Material Review and Approval, Form and Logbook Issuance, Review and Approval of Testing Data, Review and Approval of Event Reports and Associated Corrective Actions
• Level 3: Disposition and Release of Incoming Materials, Disposition and Release of Finished Product, Document Control Activities, Review and Approval of Change Controls and controlled document changes, Special Projects as assigned
• Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
• Affirm day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
• Assist with problem identification and resolution efforts for quality related issues associated with the compounding operations.
• Assist with internal, corporate, 3rd party and federal/state inspections and audits.
• Provide contributing information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
• Maintain assigned training standard operating procedures.
• Perform other related duties as assigned.

Basic Qualifications

• College Degree and at least five to eight years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience in a required.
• Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
• Proficient in MS Office programs, including Word and Excel.
• Ability to process information rapidly from multiple sources and communication channels.
• Ability to handle a high volume of work and rapidly adapt to changing environment.

What's on Offer?

• Competitive salary
• Comprehensive benefits
• Performance package
• Ability to be part of an international leader in an expanding industry