Quality Assurance Data Management Specialist

Posting Date 1 month ago(6/21/2021 1:22 PM)
Requisition ID
2021-9180
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Quality Assurance Data Management Specialist at Cook MyoSite is responsible to ensure proper oversight and involvement of Quality Assurance (QA) relevant to data integrity (DI) for computerized, paper-based, and hybrid systems, serves as the QA Subject Matter Expert (SME) and stakeholder for DI activities, serves as the System Owner for computerized systems relevant for the Quality Unit (such as Labware LIMS), and provides QA involvement and oversight of the creation and implementation of systems to generate data for metrics for Management Review, strategic and cascaded scorecards, data analysis (including statistical analysis and trending), Annual Product Review (APR) (for commercial products, as applicable), risk assessments, continual improvement, and other efforts, as needed.

Responsibilities

• Ensures proper systems are in place for the generation, review, approval, storage, archival, retrieval of data
• Serves as SME and stakeholder for DI activities, providing proper QA oversight and involvement, where applicable
• Provide QA oversight and involvement on the development, planning, commissioning, implementation, validation, and maintenance of the computerized systems supporting all Cook Myosite processes to ensure procedural and external regulatory requirement compliance, collaborating with, and providing backup, to the QA Specialist Computerized System Validation
• Interfaces with Information Systems in the role of System Owner and ensuring appropriate interaction regarding data governance
• Works collaboratively with other departments to ensure proper QA oversight and involvement where applicable
• Collaborates with the QA role(s) for Change Management pertaining to changes in computerized systems
• Collaborates with the QA role(s) for Document Control on DI relevant for paper-based and scanned records
• Collaborates with Quality Control (QC) as System Owner for Labware LIMS. Provides input and review on creation of User Requirements, commissioning, security, access, installation, qualification, etc., as needed
• Provides input to QA on the use and oversight of MasterControl
• Provides input on the use and oversight of spreadsheets, share points, shared drives, etc. relevant for data
• Collaborates with the Training Department on the training of personnel on the ALCOA+ concepts of DI
• Serves as a training liaison to ensure all stakeholder groups have current training on systems and DI
• Serves as SME and trainer on ALCOA+ for the Quality Unit and other departments, as needed
• Serves as QA SME for DI and computerized systems for relevant deviation investigations, CAPAs, change controls, and projects
• Serves as QA SME for the establishment of systems to generate data needed to assess the health of the quality system, and the metrics needed for Management Review, Monthly Strategy Meetings, strategic and department scorecards, APR (when commercial), continual improvement, risk assessment/management, internal audits, and other efforts, as needed
• Performs data analysis to identify patterns, trends, or systemic issues so that they can be addressed to prevent recurrence as part of continual improvement efforts to ensure a robust Quality System
• Interfaces with Project Management and other departments relevant to continual improvement efforts, as applicable
• Serves as SME for software QA and the assessment of DI for external audits and internal audits & other self-assessment activities
• Participate in reviews of requirements and functional and design specifications
• Collaborate on relevant quality system documents
• Promote and exemplify quality culture and GxP environment

Qualifications

• Bachelor's degree in any life science, computer science, or related field and 1-3 years’ experience in pharmaceutical/biopharmaceutical industry or 6 years direct, relevant experience in pharmaceutical/biopharmaceutical quality assurance to provide a comparable background

• At least 1-3 years' experience with data integrity, computerized System Owner, and/or performing QA data management and analysis, generation of key performance indicators or other metrics as part of a continual improvement program in support of a Quality System in the bio/pharmaceutical or medical device industry is preferred

• Knowledge of MHRA guidance on data integrity, ISPE Good Automated Manufacturing Practices (GAMP), FDA regulation and Software Validation Guidance as well as good GxP good documentation practices is preferred
• Knowledge of similar guidance or standards ISO+IEC-62304/13485/14971/29119 considered is preferred

 

Physical Requirements:

• Ability to conduct and hear ordinary conversation and telephone communication
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
• Ability to work under specific time constraints
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
• Visual and manual acuity for working with computers and equipment
• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time

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