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University of Rochester CMSU Quality Assurance Techn III - 231998 in Rochester, New York

CMSU Quality Assurance Techn III Job ID 231998

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 077 Neuro-Ctr Health & Tech/CMSU

Schedule

8 AM-5 PM; OCC WKENDS

Responsibilities

GENERAL PURPOSE:

The primary responsibilities associated with the Laboratory Technician III position are summarized in the table below. The incumbent in the Laboratory Technician III position will be expected to possess a basic understanding of current Good Manufacturing Practices (cGMP) requirements and apply those to the monitoring of clinical trials supplies procurement, handling, storage and processing within the Clinical Materials Services Unit (CMSU).

DESCRIPTION OF RESPONSIBILITY:

  • Incoming inspection and review of all labeling, drug products and components documentation for conformance to pre-approved specifications.

  • Conduct routine sampling, inspection and testing of clinical products and packaging components to pre-approved specifications.

  • Conduct line clearance / cleanliness verifications prior to production of finishing / assembly operations.

  • In compliance with internal Standard Operating Procedures, execution of

  • documentation policies and procedures for production record control including distribution records and maintenance of filing systems.

  • Provide QA support to software set-up / model verification in the utilization of

  • ClinPro LBL ™ computerized clinical label generation system.

  • Provide input into validation protocols and implement computer system validation of computerized clinical labeling hardware and software.

  • Set-up QA metrology activities and maintain control for calibration/validation/distribution and documentation of all equipment as applicable.

SPECIFIC RESPONSIBILITIES:

  • Quality Assurance Review and Verification of Production Operations: Oversees production receiving of incoming materials, warehouse storage and inventory maintenance. (25%)

  • With Production personnel, conducts line cleaning/clearance of packaging/labeling operations, provides final shipping inspection of CMSU finished goods and oversees receipt and destruction of rejected and returned material. (20%)

  • Document Management: Accurately executes and files all documentation generated in routine departmental operations. Constantly reviews the necessity and effectiveness of existing forms and recommend appropriate changes, additions and deletions. (20%)

  • Incoming Inspection of Materials: Uses statistically based sampling plans to perform quality inspection of attributes for drug products, packaging and labeling components and assembled clinical supplies. (15%)

  • Systems Support: Provides routine QA verification of proper model generation of ClinPro LBL ™ label generation system, supports Clinpro by acting as second QA check of the execution of validation scripts, and manages metrology activities; calibration of in-process packaging equipment and environmental monitoring equipment. (15%)

  • Other job duties as assigned. (5%)

REQUIREMENTS :

  • Associate’s degree in appropriate field, some college desirable. A minimum 2 years of experience, preferably in the pharmaceutical industry and/or clinical trial supply experience. Or equivalent combination of education and experience.

  • Working knowledge of GMPs along with computer skills (Word, Excel), excellent interpersonal and communication skills, including written communication.

  • Ability to work well in a team environment.

  • Strong attention to detail and organizational skills.

NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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