Quality Assurance Computer Systems Specialist

Posting Date 3 weeks ago(2/2/2018 4:48 PM)
Requisition ID
2018-3827
Job Location(s)
Pittsburgh PA United States
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Quality Assurance Computer Systems Specialist.  The Quality Assurance Computer Systems Specialist will provide QA oversight of the development, planning, implementation, and maintenance of QMS computer systems at Cook MyoSite, Inc. to ensure procedural and external regulatory requirements are being met.

Responsibilities

• Knowledge of, and ability to apply, software oriented world-wide regulatory requirements to insure compliant computer system installation and application operation for both configured and custom systems
• Participate in requirements, functional and design specification reviews
• Participate in customer and audits as software QA subject matter expert
• Create/compile validation documentation necessary to meet FDA and international requirements
• Lead the approval of validation deliverables
• Function as a quality subject matter expert in computer systems, as a quality representative on project teams, and be capable of responding to auditors’ and inspectors’ questions

• Perform deviation management activities
• Participate in risk assessments
• Conduct and document training events

• Author quality system documents
• Perform Change Management activities related to computer systems
• Perform additional activities related to overall Quality Assurance as requested by management, e.g. audits, vendor qualifications
• Promote GLP/cGMP environment and follows procedural guidelines

Qualifications

• Bachelor's degree in any Life Science, Computer Science, related Engineering field, or and/or at least 5 years of relevant QA computer system experience
• Demonstrable knowledge of ISPE Good Automated Manufacturing Practices (GAMP), FDA Software Validation Guidance, and GxP good documentation practices preferred. Knowledge of similar guidance or standards ISO+IEC-62304/13485/14971/29119 considered

• Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
• Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager Proficiency in MS Office and other general office equipment 

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

 

Physical Requirements:

• General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
• Ability to conduct and hear ordinary conversation and telephone communication
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
• Visual and manual acuity for working with computers and equipment

• Must be able to lift/push/pull up to 25 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 appropriate shoes required on as needed basis
• 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

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