Quality Assurance Associate
- Understands and enforces all standard operating procedures, forms, training documents, work instructions, etc.
- Assists the Quality Assurance Supervisor in ensuring compliance with quality plans, documentation requirements, FDA and ISO standards, and other regulatory agency requirements.
- Reviews laboratory data and data packets for documentation errors and completeness.
- Guides laboratory staff for the detection and resolution of any issues dealing with quality.
- Identifies causes of quality problems, documents them, and devises solutions and corrections.
- Assists with reporting laboratory key performance indicators.
- Reviews equipment IQ/OQ/PQ protocols and reports.
- Reviews certificate of analysis for sample release.
- Scans, uploads, and organizes laboratory document and performs audits of documents.
Quality Assurance Associate II: In addition to the essential duties listed under the Quality Assurance Associate I, this role will also be responsible for:
- Helps review and update standard operating procedures, forms, and trainings for updates per regulatory documents.
- Helps with laboratory comprehension of Quality Assurance and appropriate documentation for consistent and accurate execution within the laboratory.
- Reviews, approves, and tracks quality event instances.
- Performs CAPA escalation for laboratory improvement and correction.
- Helps maintain Quality Assurance and Laboratory Programs (equipment, training, environmental monitoring, maintenance, etc.)
- Supports the laboratory in responding to customer complaints and formulating corrective actions when needed.
- Helps with onboarding new employees through general trainings.
- Identifies key issues and improvements with certificate of analysis from testing.
Job Type: Full-time
Pay: $20.00 - $22.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience level:
- 1 year
- 2 years
- 3 years
- No experience needed
- Under 1 year
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
- In-person
- Manufacturing facility
- Office
Ability to Commute:
- Phoenix, AZ 85023 (Required)
Ability to Relocate:
- Phoenix, AZ 85023: Relocate before starting work (Required)
Work Location: In person