CMSU Quality Assurance Technician IV - University of Rochester

GENERAL PURPOSE: In addition to being able to satisfy all of the requirements associated with the Clinical Research Quality Assurance Technician IV position, the incumbent in the Clinical Research Quality Assurance Technician IV position will be expected to act independently in the areas of review and approval of critical documents; SOP’s, Process Orders and CMSS documents. The QA Tech IV will be responsible for the execution of IQ/OQ/PQ validations of CMSU equipment and temperature mapping/monitoring of CMSU cold room, warehouse, processing rooms, refrigerators and freezers. Additionally, participate more directly in regulatory and client audits as well as represent CMSU at business development functions and engaging with new and existing clients. **RESPONSIBILITIES:** **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. + 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. **Quality Assurance Review and Verification of Production Operations:** + Oversees production receiving of incoming materials, warehouse storage and inventory maintenance. 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. Authorized to issue final QA releases for inspected labeling, staged and inspected pull and ships, non-drug-device clinical materials and other items as assigned by the Director QA. + Conduct line clearance / cleanliness verifications prior to production of finishing / assembly operations. **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. + 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. **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 equipment and environmental monitoring equipment. + 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. **Internal Compliance Review (Internal Audits):** + Conducts internal audits, retrospectively, of project records, facility management and SOP’s to establish the level of compliance to internal policies and procedures, project requirements. Audit findings are reported to the respective functional manager for responses and corrective actions. + Conduct internal compliance audits of CMSU operations, in accordance with internal procedures, and report findings to CMSU management. Participate in adoption of Corrective and Preventative Action (CAPA) plans. **Technical Writing:** + Write and update new and existing SOP’s as needed. Author validation protocols as necessary for new and existing equipment. + Writing and periodic review of internal Standard Operating Procedures. **QA Liaison to External Entities:** + Participate in problem investigations (product complaints) from external, investigational sites. Work with clients on certain aspects of project related issues. Conduct and document follow-up investigations as needed to resolve quality related issues. + Assist in and participate in problem investigations both internally and at investigational sites. + Act as the QA liaison to external client inquiries regarding project related issues. + Follow-up with clinical trial sites in response to inquires and resolve problems. **Technical Document Review:** + As a designee of the Managers position, be responsible for review and approval of SOP’s, Process orders and CMSS documents. + Writing of validation protocols that support CMSU infrastructure and equipment. **Management Responsibilities:** + Supervise and train other QA technicians, participate directly in external audits and represent CMSU QA function at external meetings. + Conduct training of other QA technicians that support the QA function within CMSU. Other duties as assigned. **QUALIFICATIONS:** + High School diploma or GED required. + Bachelor’s degree in Health Science, Biology, Chemistry, or other science related field of study preferred. + 5+ years of pharmaceutical industry experience and/or clinical trial supply experience, supervisory experience, strong working knowledge of GMPs along with computer skills (Word, Excel) required. + Or equivalent combination of education and experience required + Excellent interpersonal and communication skills, including written communication. + Ability to work well in a team environment. + Strong working knowledge of GMPs along with computer skills (Word, Excel). + Strong attention to detail and organizational skills. 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. **Pay Range** Pay Range: $18.89 - $26.44 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._ **Location:** School of Medicine & Dentistry **Full/Part Time:** Full-Time **Opening:** Full Time 40 hours Grade 079 Neuro-Ctr Human Exp Ther/CMSU **Schedule:** 8 AM-5 PM; OCC WKNDS