Quality Technician - Permanent - Birmingham, AL
Be the quality gatekeeper who keeps patients safe and products flawless.
Proclinical is seeking a Quality Technician to join a team in the US.
Primary Responsibilities:
The successful candidate will ensure that compounded products meet current Good Manufacturing Practices (GMP) and internal specifications. You will perform manual and automated quality assurance checks on in-process products and finished goods while collaborating with the Quality Department to deliver high-quality products to consumers. Strong organizational skills and the ability to prioritize tasks are essential for success in this position.
Skills & Requirements:
- Experience in compounding, cGMP, or laboratory settings preferred.
- High school diploma required; Associate's or bachelor's degree in health sciences or microbiology preferred.
- Ability to follow gowning and garbing procedures as outlined in site SOPs.
- Strong written communication and interpersonal skills.
- Organizational skills with attention to detail and initiative.
- Problem-solving and analytical abilities.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- 20/20 vision (aided or unaided) for visual inspection of finished drug products.
- Physical ability to sit, stand, lift up to 40 pounds, and use computer-related equipment.
The Quality Technician's responsibilities will be:
- Collect and send samples of compounded sterile preparations (CSPs) for sterility, potency, and endotoxin testing.
- Conduct environmental monitoring, including air and surface sampling in cleanrooms, to ensure regulatory compliance.
- Perform visual inspections of finished drug products.
- Maintain incubation schedules for environmental monitoring sample plates and document results in reports and batch records.
- Ensure accurate and thorough documentation of all testing and inspections.
- Review batch records to verify adherence to procedures and compliance with FDA 503B regulations, USP standards, and internal SOPs.
- Assist in internal and external audits to ensure regulatory compliance.
- Collaborate with the Quality Assurance (QA) team to implement corrective and preventive actions (CAPAs).
- Participate in root cause analysis to identify sources of defects or quality issues.
- Ensure proper calibration and maintenance of QC laboratory equipment.
- Review draft and executed batch records, approve product label proofs, and release pharmaceutical products.
- Contribute to continuous improvement initiatives for quality control processes.
- Provide input on QC methods and assist in developing new testing procedures.
- Train personnel on SOPs, handwashing, garbing, and QC best practices.
- Stay updated on regulations, guidelines, and techniques related to quality control in 503B compounding.
- Oversee validation projects, deviation investigations, CAPA, and Out-of-Specifications (OOS) investigations.
- Prepare and review QC sections of regulatory submissions.
- Conduct internal audits, gap analyses, and assist with external regulatory inspections.
- Maintain quality records, including equipment calibration, training, deviation investigations, and environmental monitoring.
- Approve incoming materials, in-process production, and finished products.
- Participate in investigations into deviations, OOS results, or product complaints.
- Collaborate with QA to resolve issues and prevent recurrence.
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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