Job description

The Quality Assurance Analyst overall responsibility is to ensure company and customer quality standards are being met. They work under the supervision of the quality assurance supervisor where they maintain the quality management systems, perform audits, monitor quality systems, and communicate issues to laboratory management.

DUTIES AND RESPONSIBILITIES

The following tasks are performed; however, other duties may be assigned.

• Creates, reviews and controls standard operating procedures, standard test procedures, forms, training documents, and work instructions, etc.
• Assists the Quality Assurance Supervisor to ensure compliance with quality plans, documentation requirements, ISO standards and other regulatory agency requirements
• Reviews laboratory data and data packets for documentation errors and completeness
• Provides guidance to laboratory staff for detection and resolution of any issues dealing with quality
• Supports the laboratory in responding to customer complaints and formulating corrective actions when needed
• Provides mentorship to quality assurance technicians and facilitates continuing education opportunities
• Provides training on procedures, FDA regulations, cGMP, and quality documents
• Assists with onboarding orientation activities for new laboratory personnel
• Identifies causes of quality problems, documents them and devises solutions and corrections
• Develops new Quality Assurance and Laboratory programs (environmental monitoring, training, equipment control and maintenance, etc.)
• Evaluates analytical methods and stability indicating studies for accuracy and completeness
• Conducts internal audits and contract laboratory audits.
• Performs technical data audits
• Participates in external audits from state boards of pharmacy, certifying institutions, customers, and regulatory bodies
• Conducts internal evaluations for compliance with USP, FDA, ICH, ISO, etc. and performs GAP analysis to determine areas of concern or improvement within the laboratory
• Assists with reporting of laboratory key performance indicators
• Reviews equipment IQ/OQ/PQ protocols and reports
• Compiles laboratory key performance indicators and reviews them with the Quality Assurance Supervisor
• Performs vendor qualifications
• In the absence of the Quality Assurance Supervisor, the Quality Assurance Analyst III will act as lead of the quality assurance team

Job Type: Full-time

Pay: $62,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Phoenix, AZ 85085: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Are you familiar with 21 CFR 210 and 211, 21 CFR 820, 21 CFR 11?
• What is the best email to reach you by?

Experience:

• Quality systems & document control: 5 years (Preferred)
• Lab tech: 1 year (Preferred)

Work Location: In person

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