Quality Assurance Technician

Position Title: Quality Assurance / Quality Control TechnicianReports To: Quality Assurance ManagerPosition Type & Location: Full-time, Contract to Hire | Birmingham, ALPosition OverviewThe 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 ResponsibilitiesIssue, 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 RequiredBachelor'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 & BenefitsPay: $22.00-$25.00/hr to startBenefits: 401(k) with matching, health, dental, vision, life insurance, paid time offSchedule: Day shift / Night shift optionsWork Location: On-site, Birmingham, AL

Created: 2025-10-02