Quality Assurance Technician

Position Title: Quality Assurance / Quality Control Technician

Reports To: Quality Assurance Manager

Position Type & Location: Full-time, Contract to Hire | Birmingham, AL

Position Overview

The Quality Assurance / Quality Control (QA/QC) Technician is responsible for supporting quality assurance and control activities in a 503B outsourcing facility. This role combines document control, compliance, and batch record review with hands-on inspection, labeling, and microbiology-related tasks to ensure adherence to cGMP, FDA, ISO, and other regulatory requirements. The QA/QC Technician will play an important role in maintaining the highest standards of product integrity, safety, and regulatory compliance.

Essential Duties and Responsibilities

• Issue, review, and maintain Master Batch Records (MBRs) for accuracy and compliance.
• Perform document control tasks, including scanning, filing, SharePoint management, and archival projects.
• Receive, sign in, and properly store incoming materials; ensure paperwork and approval processes are completed.
• Operate specialized label printing software (training provided), verify label accuracy (dosage, information, compliance), and monitor output for quality.
• Ensure all labeling, documentation, and records are accurate and properly maintained.
• Conduct routine quality control tests and inspections to verify compliance with cGMP, FDA, ISO 13485, HACCP, and ISO 9001 standards.
• Utilize microbiology-related equipment for sample incubation and cleanliness verification in controlled environments.
• Gown properly and follow strict cleanroom/aseptic procedures to maintain product safety and regulatory compliance.
• Collaborate with production teams to identify and resolve quality issues, supporting continuous improvement and corrective actions.
• Assist in internal audits and contribute to the development of quality assurance protocols.
• Stay current with industry regulations, guidelines, and best practices in pharmaceutical and healthcare manufacturing.

Skills and Experience Required

• Bachelor’s degree preferred (science, microbiology, or related field).
• Minimum 2 years of quality experience in an FDA-regulated environment (503B outsourcing, pharmaceutical, medical device, or compounding background preferred).
• Knowledge of cGMP guidelines, FDA regulatory requirements, and quality system standards.
• Familiarity with microbiology principles and aseptic/cleanroom practices.
• Proficiency in Microsoft Office, Adobe, eQMS, and document/inventory management systems.
• Strong technical writing skills with the ability to draft, edit, and review controlled documents.
• Excellent organizational skills, attention to detail, and ability to multitask in a fast-paced environment.
• Strong communication and teamwork skills; able to work independently and collaboratively.

Compensation & Benefits

• Pay: $22.00-$25.00/hr to start
• Benefits: 401(k) with matching, health, dental, vision, life insurance, paid time off
• Schedule: Day shift / Night shift options
• Work Location: On-site, Birmingham, AL