University of Rochester

CMSU Research Quality Assurance Coordinator III

HENRIETTA, NYPosted 24 days ago

Job summary

  • Job post source

    This job is directly from University of Rochester

  • Job overview

    The CMSU Research Quality Assurance Coordinator III at University of Rochester ensures compliance with cGMP in clinical trial supply processes, impacting quality and regulatory adherence.

  • Responsibilities and impact

    The role involves reviewing and approving critical documents, conducting equipment validations, managing inspections, audits, documentation, and serving as a liaison with clients and regulatory bodies to maintain quality standards.

  • Compensation and benefits

    The compensation range is $24.91 to $34.87 per hour, with salary set based on experience and qualifications; benefits details are not specified.

  • Experience and skills

    Requires an Associate's degree with 3-5 years of relevant pharmaceutical or clinical trial supply experience; Bachelor's preferred; strong GMP knowledge, computer skills, communication, and organizational abilities are essential.

  • Career development

    Opportunities include supervising and training QA coordinators, participating in audits, and representing CMSU at industry events, supporting professional growth in quality assurance.

  • Work environment and culture

    The University of Rochester values equity, leadership, integrity, openness, respect, and accountability, fostering an inclusive and welcoming environment for all employees.

  • Company information

    University of Rochester is committed to excellence and inclusivity, supporting research and clinical trials with a focus on continuous improvement and community values.

  • Team overview

    The candidate will work within the Clinical Materials Services Unit QA team, collaborating with production personnel and management to ensure quality compliance.

  • Job location and travel

    The position is based at 150 Metro Park, Suite C, Rochester, New York, with a full-time day shift schedule.

  • Unique job features

    The role includes unique responsibilities like executing IQ/OQ/PQ validations, managing clinical label generation systems, and direct involvement in regulatory audits and client engagements.

Company overview

The University of Rochester is a private research university located in Rochester, New York, known for its strong emphasis on interdisciplinary education and research. It generates revenue through tuition, research grants, healthcare services via its Medical Center, and philanthropic contributions. Founded in 1850, the university has a rich history of innovation and is home to notable institutions such as the Eastman School of Music and the Laboratory for Laser Energetics.

How to land this job

  • Tailor your resume to highlight your advanced understanding of cGMP regulations, particularly 21 CFR FDA standards, and your experience in quality assurance within clinical trial supply environments at the University of Rochester.

  • Emphasize your skills in document review and approval, IQ/OQ/PQ validations, temperature monitoring, and internal audit participation to align with the CMSU Research Quality Assurance Coordinator III role’s core responsibilities.

  • Apply through multiple platforms such as the University of Rochester’s official careers website, LinkedIn, and relevant pharmaceutical or clinical trial job boards to maximize your application visibility.

  • Connect with current QA team members or CMSU division employees on LinkedIn, using ice breakers like commenting on recent University of Rochester research initiatives or asking about their experience with CMSU’s quality assurance processes.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'cGMP,' 'clinical trial supplies,' 'IQ/OQ/PQ validation,' 'document management,' and 'internal audits' to ensure it passes automated screenings effectively.

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