Quality Assurance Specialist

Bayside Solutions; Salt Lake City (UT); On-site; USD 70,000 - 100,000; Full time

Job summary

Bayside Solutions is seeking a Quality Assurance Specialist to support GMP operations with strong floor-based QA involvement in Salt Lake City. The role focuses on ensuring the highest quality standards across manufacturing and warehouse areas, reviewing batch records, test data, and logs to drive right-first-time execution.

Qualified candidates have 4+ years in biotech manufacturing or QA, familiarity with large molecule drug substance production, and solid knowledge of GMP standards.

Qualifications

• 4+ years in Biotech Manufacturing/QA/MSAT in GMP, regulated facilities.
• Familiarity with large molecule drug substance manufacturing.
• Knowledge of USP/Ph. Eur./FDA/ISO/GMP standards and guidance.
• Experience working in GMP-regulated environments is required.
• Strong verbal and written communication, attention to detail.
• Proven ability to execute with accuracy and proactive approach.
• Familiar with MasterControl and electronic batch records.

Responsibilities

• Execute QA on the Floor program – 50% of the time.
• Conduct manufacturing and warehouse walkthroughs to ensure quality.
• Provide quality support to manufacturing operations.
• Review batch records, test data, and logs for compliance.
• Disposition materials and escalate quality issues when needed.
• Collaborate with manufacturing floor teams on quality matters.
• Perform other duties as assigned.

Skills

QA on the Floor

Manufacturing walkthroughs

Quality assurance

MSAT

GMP knowledge

Documentation review

Education

BS in a scientific discipline

Tools

MasterControl

Electronic Batch Records

Job description

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
• Escalate quality issues
• Work with manufacturing on the floor proactively and in collaboration
• Other duties as assigned

Requirements and Qualifications:

• 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
• 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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