Quality Assurance Specialist

Quality Assurance Specialist

W2 Contract

Pay Rate: $30 - $40 per hour

Location: Salt Lake City, UT - Onsite Role

Job Summary:

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.

Duties and 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

Desired Skills and Experience

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

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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