CMSU GMP Operations Technician III

University of Rochester | Rochester, NY

Posted Date 8/03/2023
Description

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 CMSU Clinical Research Packaging Technician III position are summarized in the table below. The incumbent will be expected to possess a basic understanding of the current Good Manufacturing Practices (cGMP) requirements and apply those to the processing of clinical trials supplies within the Clinical Materials Services Unit (CMSU).

Laboratory Technician

Description of Responsibility

Level III

Level IV

Level V

Provide quality, timely, consistent clinical trial drug and device packaging in strict compliance to Good Manufacturing Practices (GMPs).

X

X

X

Organize and maintain a GMP compliant storage and processing area within the CMSU facility.

X

X

X

Determine departmental needs and order all packaging components critical to the assembly of finished study drug/device kits/packages from approved vendors.

X

X

X

Organize and maintain a GMP compliant storage facility.

X

X

X

Maintain a GMP compliant system for the return and accounting of all returned investigational products.

X

X

X

Generate, organize and maintain documents in compliance with requirements of cGMPs.

X

X

X

Handling of drugs, devices and components in accordance with cGMPs during receipt, warehousing, processing, distribution, return and destruction.

X

X

X

Follow-up with clinical trial sites in response to inquiries and resolve problems.

X

X

*Familiarity with ClinPro Labeling system and ability to produce clinical labels from existing model.

X

X

*With oversight from functional supervisor, create model within ClinPro Labeling System to produce clinical labels.

X

X

*Independently create model within ClinPro labeling system.

X

Delivery of Training Programs

X

X

Development of Training Programs

X

Execution of I/O/PQ and Production Validation Protocols for packaging equipment

X

X

With oversight from functional manager, generate draft version of Standard Operating Procedures (SOPs), Processing Order and Clinical Material Specification Sheet (CMSS) documents.

X

X

**Experience with handling controlled substances in compliance with NYS and Federal [Drug Enforcement Agency (DEA)] requirements.

X

X

Working independently to generate SOP’s, Processing Order and CMSS documents from draft stage through to final approved documents.

X

Participate directly in inspections by regulatory agencies and external auditors.

X

Participate in the development of packaging equipment requirements, assessment of equipment capabilities and recommendations for purchase,

X

Assume interim supervisory responsibilities.

X

Participate in development of budget worksheet in response to Requests For Proposals (RFPs).

X

Develop agenda and participate in team presentation of CMSU capabilities during meetings/teleconferences with possible new and established clients.

X

Represent the CMSU at industry conference exhibits when needed.

X

* Applies to Packaging Technician designated as back-up to Labeling Supervisor

** This responsibility applies in the event that the CMSU becomes registered to handle controlled substances.

SPECIFIC RESPONSIBILITIES:

  • Processing Operations: To follow GMPs and high quality standards in the labeling, packaging and distribution of clinical materials according to written procedures. Must have thorough understanding of the relation of the required labeling to the overall study design. Foster an environment of continuous improvement by remaining alert to opportunities for improvement and offering suggestions. (25%)
  • Inventory Control: Anticipate departmental needs based on established clinical plans for the ordering of all packaging components critical to the assembly of finished study supplies. Make necessary adjustments to computer based inventories to reflect accurate stock levels. (25%)
  • *Master and utilize the various capabilities of the clinical labeling software in meeting the challenge of providing compliant labels in a timely fashion and cross train other appropriate Clinical Materials Services Unit (CMSU) personnel in the use of the labeling system. (20%)
  • Document Management: Must accurately execute and file all documentation generated in routine departmental operations. Must constantly review the necessity and effectiveness of existing forms and recommend appropriate changes, additions and deletions. (15%)
  • Facility Operations: Organize and maintain a GMP compliant facility. Duties include shipping, receiving, accurate record keeping and routine cleaning of processing rooms and drug/device and component storage areas. (10%)

Other job duties as assigned. (5%)

*Applies to Packaging Technician designated as back-up to Labeling Supervisor in place of Document Generation.

REQUIREMENTS:

  • Associate’s degree and a minimum 2 years of pharmaceutical industry experience and/or clinical trial supply experience; or equivalent combination of education and experience.
  • Working knowledge of GMPs along with computer skills (Word, Excel), and excellent oral and written communication skills.
  • Ability to work well in a team environment where all work product is reviewed and approved by the Quality Assurance group before any work product leaves CMSU.
  • Strong attention to detail and ability to multi-task in a fast paced environment.

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

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $ 16.49 - $ 23.08 Hourly

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Employment Type
Full Time

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