Quality Assurance Technician
Express Employment Professionals - Birmingham, AL SouthBirmingham, AL, United Statesjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionBachelor’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. 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
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
Compensation & Benefits
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Quality Assurance Technician • Birmingham, AL, United States
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