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University of Rochester Administrator II (Sr. Quality Analyst, CMSU) - 237461 in Rochester, New York

Administrator II (Sr. Quality Analyst, CMSU) Job ID 237461

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

Full Time 40 hours Grade 055 Neuro-Ctr Health & Tech/CMSU

Schedule

8 AM-5 PM

Responsibilities

GENERAL PURPOSE:

Conducts assessment of analytical reports, batch records and other supporting documentation for clinical materials received by the Clinical Materials Services Unit (CMSU) to ensure compliance with specific federal regulatory requirements. Provides support as needed for all Quality Assurance (QA) activities and acts as the back-up in the absence of the Director QA. Includes but is not limited to the following:

Supports the Director of Quality Assurance as needed by providing over-sight and critical review of documentation supporting the manufacturing, packaging, analytical testing and retest date management for all clinical investigational materials received by the CMSU for processing, labeling and distribution to clinical sites. Critical review to ensure that all batch records, analytical reports, stability reports and protocols comply with the 21CFR regulations covering the manufacturing and packaging of clinical trial supplies. Working closely with the Director of Quality, continually modify, as necessary, current quality systems to comply with the Medical Device regulation (21 CFR Part 820) and the European Commission (EU) Clinical Trials Directive assuring the safe and compliant handling of investigational drugs and devices.

This position is responsible for ensuring that the manufacturing, analytical testing and stability data for the drug and device products received by the CMSU for processing, labeling and distribution to clinical sites fully complies with the requirements of the applicable FDA 21CFR regulations. The position assists in ensuring that all clinical research projects are carried out to the standards set forth by the International Conference on Harmonization (ICH) covering Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), for both FDA and EU regulations covering investigational drugs and devices.

SPECIFIC RESPONSIBILITIES:

  • Provide compliance support for the release of clinical trial supplies to allow for timely distribution in accordance with the international standards of GCP/GMP regulations and client requirements. Review key documents provided by clinical study material manufacturers or their designated contract Manufacturers/Packagers/Analytical Services to determine if they are complete, accurate, regulatory compliant and sufficient to support release of the study material for use by the CMSU.

  • Manage the assignment, tracking and updating of investigational product retest dates based on the review and assessment of supporting stability data provided by the manufacturer to ensure that the quality and safety of the investigational product is maintained throughout the clinical trial.

  • As necessary liaise with clients/vendors directly to obtain needed reports to ensure compliance with project and regulatory standards.

  • Provide support in the day to day activities of the QA dept. including but not limited to: Label generation, labeling inspection and release, QA inspection of pull and ship documentation, incoming material inspections and processing related inspections.

  • Provide oversight and guidance to CMSU staff in regards to compliance to all internal Quality Assurance (QA) systems including investigational drug and device procedures and processes – CAPA (corrective and preventive actions) and CQI (continuous quality improvement).

  • Input and approval authority into all clinical study documentation generated by the CMSU to ensure federal and international regulatory standards are met.

  • Act as a back-up in the absence of the Director Quality Assurance.

  • Participate in external and internal inspections from client companies and international regulatory authorities.

    Other duties as assigned

REQUIREMENTS:

  • BS degree in biology, microbiology, chemistry, chemical engineering, or related scientific field.

  • 8 years in Quality Assurance, Research & Development and/or Regulatory experience in the pharmaceutical or device industries required.

  • Minimum of 5 years demonstrated analytical laboratory experience in a pharmaceutical research, stability or finished product testing lab required.

  • or equivalent combination of education and experience required

  • Strong working knowledge of International GCP/GMPs, compliance auditing, QA or prodcut development experience, and GCP/GMP Document Management systems.

  • Strong interpersonal and communication skills, including writing skills and experience in communicating effectively with senior leadership required

  • Proven record of working effectively in a team environment and independently required

  • Strong working knowledge of investigational drug and device handling and distribution as well as the conduct of clinical trials required.

  • Strong organizational and computer skills required

  • Project leadership experience a plus.

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

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