Investigations Writer II

Posting Date 3 weeks ago(9/7/2022 10:58 AM)
Requisition ID
2022-11377
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 Investigations Writer II at Cook MyoSite, Inc. is responsible for completing deviation investigations writing in a compliant and timely manner. The Investigations Writer II is responsible for assessing need for corrective and preventive action with stakeholders and QA and escalating any issue with investigation work or timeline to Team Lead.

Responsibilities

• Conduct deviation investigations in compliance with Cook Myosite quality requirements and timeline
• Conduct activities such as interviews, walkthrough, physical examinations of evidence, and/or literature search to complete investigations
• Ensure investigations are followed and closed out in a timely manner
• Communicate status of deviation investigations and escalate roadblocks to team lead.
• Participate in investigation discussion meetings as subject matter expert
• Apply analysis tools to identify the appropriate root cause(s) for the deviation
• Evaluate requirement of corrective and preventive action (CAPA) in investigation process working with QA specialist, process owners and system owners and develop CAPAs with clear language
• Assist in CAPA implementation and CAPA effectiveness check
• Develop standard operating procedures and any other quality documentation
• Responsible for reporting data to team lead on status of daily tasks and metrics

Qualifications

• Undergraduate degree in chemical engineering, biology, biotechnology, and 3 years direct, relevant experience in investigations writing, CAPA management and change control process to provide a comparable background

• Minimum of 3 years' experience in Investigations writing

• Experience with CAPA process is preferred
• Knowledge of electronic documents management system is preferred
• Knowledge of root cause analysis tools is preferred

• 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

 

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 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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