Systems Quality Assurance Manager Rochester, NY
Systems Quality Assurance Manager
Job ID: Job-2144
Job Title: Systems Quality Assurance Manager
location: Rochester, NY
Jobtype: Permanent
Rate: $75K - $85K
Primary Skills:
Description: Required Skills
Expert knowledge and application of SQA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
Expert knowledge and application of Systems Development Lifecycle (SDLC), Change Control and SOP development.
Expert knowledge of FDA and industry standards (21 CFR Part 11, 210, 211, 820, GAMP)
Excellent communication, presentation and meeting skills.
Ability to think strategically and exhibit effective analytical, troubleshooting, and problem solving skills.
Effective interpersonal and leadership skills and the ability to work with others in team environment.
Ability to motivate and manage scientific, clinical and technical personnel.
Responsible for strategy, planning and execution of the Systems Quality Assurance function including the creation and execution of system validation activities throughout all phases of the system development process.
Develop validation strategy documents, SOPs, IQ/OQ/PQ, and create validation summary reports.
Provide guidance and oversight of validation activities for projects involving GxP relevant systems.
Work closely with project team members to incorporate appropriate quality and compliance into the system lifecycle.
Provide management, guidance, and oversight of testing activities.
Review and approved computer system validation work products
Provide input to validation planning
Provide tactical direction and guidance for changes to regulated computer systems.
Support internal and external compliance audits.
Follows and improves departmental processes and standard operating procedures
Assist with project estimation, planning and tracking of testing and implementation tasks.
Anticipate dependencies and delays and bring them to the manager''s attention.
Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume. I will only respond to resumes that demonstrate a fit for the role.
PAID RELOCATION. ONLY THOSE AUTHORIZED TO WORK IN THE US. VISA TRANSFERS ARE NOT AVAILABLE AT THIS TIME. NO 3RD PARTIES. NO OVERSEAS RESUMES, PLEASE.
Watch and subscribe to TheBigGameHuntrTV on YouTube for "No B.S." job search and hiring advice. To receive a complimentary subscription to my job search ezine, No B.S. Job Search Advice, go to http://www.JeffAltman.com to subscribe. Receive tweets from Twitter with job search tips and job listings -@ TheBigGameHuntr
Job ID: Job-2144
Job Title: Systems Quality Assurance Manager
location: Rochester, NY
Jobtype: Permanent
Rate: $75K - $85K
Primary Skills:
Description: Required Skills
Expert knowledge and application of SQA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
Expert knowledge and application of Systems Development Lifecycle (SDLC), Change Control and SOP development.
Expert knowledge of FDA and industry standards (21 CFR Part 11, 210, 211, 820, GAMP)
Excellent communication, presentation and meeting skills.
Ability to think strategically and exhibit effective analytical, troubleshooting, and problem solving skills.
Effective interpersonal and leadership skills and the ability to work with others in team environment.
Ability to motivate and manage scientific, clinical and technical personnel.
Responsible for strategy, planning and execution of the Systems Quality Assurance function including the creation and execution of system validation activities throughout all phases of the system development process.
Develop validation strategy documents, SOPs, IQ/OQ/PQ, and create validation summary reports.
Provide guidance and oversight of validation activities for projects involving GxP relevant systems.
Work closely with project team members to incorporate appropriate quality and compliance into the system lifecycle.
Provide management, guidance, and oversight of testing activities.
Review and approved computer system validation work products
Provide input to validation planning
Provide tactical direction and guidance for changes to regulated computer systems.
Support internal and external compliance audits.
Follows and improves departmental processes and standard operating procedures
Assist with project estimation, planning and tracking of testing and implementation tasks.
Anticipate dependencies and delays and bring them to the manager''s attention.
Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume. I will only respond to resumes that demonstrate a fit for the role.
PAID RELOCATION. ONLY THOSE AUTHORIZED TO WORK IN THE US. VISA TRANSFERS ARE NOT AVAILABLE AT THIS TIME. NO 3RD PARTIES. NO OVERSEAS RESUMES, PLEASE.
Watch and subscribe to TheBigGameHuntrTV on YouTube for "No B.S." job search and hiring advice. To receive a complimentary subscription to my job search ezine, No B.S. Job Search Advice, go to http://www.JeffAltman.com to subscribe. Receive tweets from Twitter with job search tips and job listings -@ TheBigGameHuntr
posted by Unknown at 5:33 AM
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