Quality Assurance Technician II

About the role

Performs inspections, sampling, auditing, and documentation reviews to ensure compliance with quality standards. Coordinates with manufacturing personnel for best practices; communicates non-conforming circumstances to Quality Supervisor for dispositions; assists in making corrective measures. Assists in non-conformance investigations.

Designated Quality Responsibilities: Performs materials and product inspections and releases; document review and approval, identification and communication to management of non-conforming materials and products; cGMP compliance.

Responsibilities

• Performs incoming AQL inspection on raw materials/finished goods/components according to written standard operating procedures, work instructions, and specifications in Receiving.
• Responsible for pulling and submitting a representative sample for at least identity and microbial testing.
• Approves and releases incoming raw materials/finished goods/components.
• Verifies and performs checks on cleaning processes as established in procedures pertaining to operation area before, during, and after production. Completes associated logs.
• Performs batch record review and approval as outlined to product specification.
• Performs, monitors, and documents 1st article inspection and in-process checks in filling rooms in operation area.
• Verifies calibration and verifications on equipment logs in operation area.
• Responsible for pulling in-process and finished good samples for QC testing to verify purity, identity, specificity, and conformance to product specification.
• Responsible for performing AQL inspection on finished product.
• Responsible for reviewing and releasing finished product for shipping.
• Responsible for label control; process for received and released labels from Quarantine are followed.
• Reports deviations, product, and in-process issues to Quality management.
• Works with and supports Operation functions which involve Quality.
• Complies with FDA, cGMP, and other requirements and enforces adherence to requirements.
• Assists with on-the-job training for production and quality staff regarding quality requirements.

Requirements

• Two years’ acceptable performance as Technician I or equivalent experience.
• 2-5 years of QA Tech experience in a food juice, dietary supplement, device, or drug facility.
• Knowledge and experience with applicable FDA regulation and cGMP requirements required.
• High School Diploma or GED required. Associate’s or Bachelor’s degree preferred.
• Attention to detail and organization of tasks and workloads. Must be able to identify small defects.
• Excellent communication skills in writing, listening, and responding with feedback within quality and production.
• Strong organizational abilities.
• Bilingual Spanish and English preferred.
• Basic computer skills; data entry, Microsoft Office suite required.

Work Environment

• Long periods of standing, bending, and repeated lifting (35-45 lbs).
• Moderate noise level (Manufacturing environment: clean rooms and warehouse).