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Quality Assurance Technician (Birmingham)

Quality Assurance Technician (Birmingham)

Express Employment Professionals - Birmingham, AL SouthBirmingham, AL, US
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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

  • Bachelors 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
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    Quality Assurance Technician • Birmingham, AL, US