Quality Assurance Specialist

About the role

The Quality Assurance Specialist will play a role in supporting GMP operations and ensuring the highest quality standards are being met in all areas across the facility, with a heavy focus on the floor support for manufacturing operations. Location: Salt Lake City, UT - Onsite Role.

Responsibilities

• Execute QA on the Floor program - 50% of the time
• Conduct manufacturing and warehouse walkthroughs
• Provide quality support to manufacturing operations
• Review batch records, test data, and logs
• Disposition materials
• Provide quality review for deviations, change controls, CAPA's
• Escalate quality issues
• Work with manufacturing on the floor proactively and in collaboration
• Other duties as assigned

Requirements and Qualifications

• BS in a core scientific discipline
• 4+ years of experience in Biotech Manufacturing / Quality Assurance / MSAT
• Familiarity with large molecule drug substance manufacturing
• Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
• Previously experienced working in a GMP-regulated facility
• Well-developed verbal and written communication skills
• Ability to closely follow quality standards and pay attention to detail
• Strong collaboration skills
• Excellence in execution through accuracy, right first time, and a proactive nature
• Familiar with Master Control, Electronic Batch Records

Skills

• GMP quality assurance, QA floor support, Biotech manufacturing/MSAT experience (4+ years)
• Large molecule drug substance manufacturing
• Manufacturing and warehouse walkthroughs
• Batch record/test data/log review
• Material disposition
• Deviation review
• Change control
• CAPA review
• Quality issue escalation
• USP/Ph. Eur./FDA/ISO standards
• MasterControl
• Electronic batch records
• Verbal and written communication
• Cross-functional collaboration
• Attention to detail
• Accurate and proactive execution
• BS in a scientific discipline

Pay

Pay Rate: $30 - $40 per hour