Clinical Labeling SpecialistCCL Clinical Systems is seeking a detail-oriented Clinical Labeling Specialist to support daily label generation and production operations for clinical trial materials. In this role, you will be responsible for preparing, printing, reviewing, documenting, and shipping clinical labels while ensuring compliance with company procedures, customer requirements, and quality standards. The ideal candidate is highly organized, possesses strong attention to detail, and is comfortable working in a regulated production environment where accuracy and confidentiality are critical.
Key Responsibilities:
Participate in pre-production reviews with the Project Leader.
Select and allocate appropriate label stock for production jobs.
Prepare production rooms and workstations for area clearance.
Print labels according to customer specifications and project requirements.
Monitor printing operations to identify and address quality issues, defects, or production concerns.
Perform reprint and integration activities for replacement labels as needed.
Prepare packaging labels and supporting materials.
Accurately document production activities and maintain required records throughout each run.
Review production documentation for completeness and accuracy before submitting to Quality Assurance (QA) for review and release.
Support shipping and fulfillment activities to meet customer requirements.
Assist with additional operational tasks as needed to support day-to-day business operations.
Qualifications & Requirements:
High School Diploma or equivalent required.
Minimum 1 year of experience in clinical label production and clinical trial booklet production.
Experience working in a regulated manufacturing, pharmaceutical, biopharmaceutical, clinical research, or healthcare environment preferred.
Working knowledge of current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).Strong proofreading skills with the ability to review printed materials, labels, and production documentation for accuracy.
Ability to follow detailed verbal and written instructions and adhere to established procedures.
Strong attention to detail with a commitment to accuracy and quality.
Ability to maintain detailed production records and documentation in accordance with quality and compliance requirements.
Basic mathematical, grammatical, and computer skills.
Effective verbal and written communication skills.
Ability to identify and resolve production issues while maintaining quality standards.
Ability to work independently and collaboratively in a fast-paced production environment.
Demonstrated ability to handle confidential customer and clinical trial information with discretion and professionalism.
Work EnvironmentCCL Clinical Systems is committed to providing a clean, safe, and professional work environment for all employees. This position requires working in a production setting where attention to detail, quality, and compliance are essential.
Confidentiality:
Due to the nature of our business, all customer-related clinical trial information is strictly confidential. Employees are required to maintain confidentiality and adhere to company policies regarding the protection of customer and clinical trial data.
