Risk Analyst

Posting Date 1 month ago(10/22/2020 3:58 PM)
Requisition ID
2020-8059
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Production/MFG/Operations

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 Risk Analyst position at Cook MyoSite, Inc. is responsible to organize and oversee quality risk management (QRM) program, leads facilitation, communication, tracking, monitoring, and reporting of quality risk assessments and mitigation/remediation actions. Supports quality management system organization processes (Investigations, CAPA, Change Controls, etc.) as needed.

Responsibilities

• Function as quality risk management subject matter expert
• Work with respective business process owners and system owners to define the risks of each of their respective quality systems and the overall controlled state and health of the system
• Ensure proactive approach to the QRM program to identify potential risk to quality, safety and efficacy of Cook Myosite products and processes
• Perform and document risk assessments as facilitator
• Monitor, track and report quality risk assessments and mitigation/remediation actions, including creation/use of appropriate risk tools for execution
• Establish and maintain compliant procedures and processes for quality risk management
• Present quality risk management program as SME during internal/external audits and regulatory inspections
• Support regulatory filings as needed
• Periodically review completed risk assessments and generate reports for continuous compliance/reassessment requirements
• Maintain the risk register for continued communication for required mitigations
• Understand current industry standards for risk management and align Cook MyoSite, Inc. procedures and activities with them
• Lead cross departmental teams for risk projects

Qualifications

• Bachelor's degree in Engineering or any Life Sciences

• 3+ years’ experience in pharmaceutical or biotech experience including QRM, quality compliance, engineering and/or validation

• Quality Risk Management certification is preferred
• Working knowledge of CAPA and Change Management processes

• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Strong understanding of ICH Q9 “Quality Risk Management”
• Understanding of ICH Q8 and Q10
• Understanding of PDA and ISPE risk management guidelines
• Must have working knowledge of risk assessment facilitation
• Strong knowledge of risk management tools, such as PHA, FMEA, Ishikawa, etc.

 

Physical Requirements:

• Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• 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 at/working in a biological safety hood with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.

• 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 but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis.

 

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