Quality Analyst (CO, Golden)

Responsibilities

• Review and approve laboratory records, batch records, SOPs, and quality documentation.
• Manage and investigate deviations, laboratory discrepancies, OOS results, CAPAs, and change controls.
• Perform quality review of analytical data to ensure accuracy, completeness, data integrity, and regulatory compliance.
• Support data trending, metric reporting, and continuous improvement activities.
• Maintain compliance with cGMP, GDP, company procedures, and applicable regulatory requirements.
• Support audits, inspections, and quality system initiatives.
• Collaborate with laboratory and operational teams to resolve quality issues and implement corrective actions.
• Perform additional duties and special projects as assigned.

Qualifications and Experience

• A High School Diploma is required.
• Minimum 1 year experience working in a GMP testing facility.
• Minimum 1 year experience reviewing deviations, CAPA's, and Change Controls.
• Experience working under FDA guidelines.
• Excellent communication skills; both verbal and written.
• Experience with Microsoft Office Suite (Word, Excel) and ability to utilize various software programs.
• Strong attention to detail.

Physical Requirements

• Must be able to lift up to 50 lbs. frequently throughout the day.
• Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time.
• Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned.

Pay Range

$30.50 - $35.50