Quality Technician Job at Proclinical (Birmingham)

Quality Technician

Proclinical

Location:
United States , Birmingham

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Be the quality gatekeeper who keeps patients safe and products flawless. Proclinical is seeking a Quality Technician to join a team in the US. 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.

Job Responsibility:

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

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

Additional Information:

Job Posted:
April 05, 2026

Employment Type:

Fulltime

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Job Link Share:

Quality Technician

Proclinical

Location:
United States , Birmingham

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 05, 2026

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