Research Qual Assurance Spec I
University of Rochester
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Job Location (Full Address):
150 Metro Park, Suite C, Rochester, New York, United States of America, 14623Opening:
Worker Subtype:
RegularTime Type:
Full timeScheduled Weekly Hours:
40Department:
400982 Neuro-Ctr Health & Tech/CMSUWork Shift:
UR - Day (United States of America)Range:
UR URG 109 HCompensation Range:
$26.90 - $37.66The 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.
Responsibilities:
GENERAL PURPOSEPossess an extensive understanding of current Good Manufacturing Practices (cGMP) as defined in 21 CFR FDA regulations and apply those to the procurement, handling, inspection, storage and processing of clinical trials supplies within the Clinical Materials Services Unit.
Expected to act independently in the areas of review and approval of critical documents; SOP’s, Process Orders and CMSS documents. The QA Lead 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.
Apply their extensive understanding of current Good Manufacturing Practices (cGMP) experiences along with strong critical thinking skills to handle responsibilities of a more complex nature within the Quality Assurance function of Clinical Materials Services Unit (CMSU).
This position is responsible for document management within the secure CMSU Document Room including proper filing, document release, tracking and management. As a team lead, will also support and allocate resources to support these activities.
ESSENTIAL FUNCTIONS
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.
- 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.
- Inspection of pre-labelled kitted/bottled product and organization, as applicable on pallets to ease of Pull and ship process.
- Supports Oversees receiving of incoming materials, warehouse storage and inventory maintenance by:
- The review and approval of all documentation associated with standard pull and ship operations (PNS) required to ship labeled product to site for use by clinical trial participants. This includes the first QA check only.
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.
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.
- 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.
- Participate directly in inspections by regulatory agencies and external auditors.
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.
- Writing of validation protocols that support CMSU infrastructure and equipment.
- Oversee the execution of IQ/OQ/PQ and Production Validation Protocols for packaging equipment.
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 inquiries and resolve problems.
- Develop agenda and participate in team presentation of CMSU capabilities during meetings/teleconferences with possible new and established clients.
- Technical Document Review: As a designee of the Managers position, be responsible for review and approval of SOP’s, Process orders and CMSS documents.
- With oversight from functional manager, Conduct review and approvals of Processing Orders and Clinical Materials Specification Sheet (CMSS)documents.
Management Responsibilities: Supervise and train other QA coordinators, participate directly in external audits and represent CMSU QA function at external meetings.
- Conduct training of other QA coordinators that support the QA function within CMSU.
- Ensure employee training files are accurate and current.
- Ensure Training Index is accurate and current.
- With oversight of the QA manager, independently conduct qualification audits of external vendors.
- Supervision and mentorship of other QA coordinators.
- Represent the CMSU at industry conference exhibits when needed.
Secure Document Room Management: This position is responsible for document management within the secure CMSU Document Room.
- Responsible for proper filing, document release, tracking and management of documentation.
- Allocate resources as appropriate to support secure Documentation room activities.
Production Release: Support management in the review and release of drug product.
- Support will include the review of Completed Production Process Orders, drug analytical documents, and stability protocols/reports, etc.
- Draft and/or review of production release memos, Note to Files, and Internal Rational release documents.
Other duties as assigned
MINIMUM EDUCATION & EXPERIENCE
- Bachelor’s degree in appropriate discipline required.
- 3-5 years of specialized work experience, preferably in the pharmaceutical industry and/or clinical trial supply experience required.
- Or equivalent combination of education and experience required.
KNOWLEDGE, SKILLS AND ABILITIES
- Ability to manage multiple and complex projects, provide status reports, and coordinate with cross-functional teams. Strong working knowledge of GMPs along with computer skills (Word, Excel).
- Excellent communication skills, including written communication.
- Strong attention to detail, excellent time management, and organizational 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.
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