Job Description
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
Job Tags
Full time, Contract work, Work at office, Night shift, Day shift,