Quality Assurance Manager
Spectraforce
Nashville, Tennessee
Remote
an hour ago
Job Description
Position Title: Quality Assurance Manager
Work Location: Remote
Assignment Duration: 06 Months
Work Schedule: PST hours preferred (EST hours okay) – Standard 8-5. Candidates may need to work outside normal business hours on occasion, particularly once per quarter for system releases.
Position Summary:
REMOTE: PST hours preferred (EST hours okay) - STANDARD 8-5. Candidates may need to work outside normal business hours on occasion, particularly once per quarter for system releases.
Ideal candidate: Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, and GCP regulations.
Key Responsibilities:
• Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
• Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
• Change Agent and advocate for the Risk Based Validation program
• Able to act as SME for multiple Quality processes (e.g. Deviations, CAPA)
• Review and Approve SOPs and associated documents
• Review/Approve Periodic Reviews for GxP Systems
• May perform software Supplier Evaluations as needed
• Support project initiatives, process improvements and or projects
• May be required to present on topics or issues to management
• May support audit & Inspections requests as needed
• May support other duties as required
Qualifications & Experience:
• Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
• Strong organizational skills, including ability to follow assignments through completion.
• Initiate and lead cross functional teams as needed
• Collaborate and communicate with higher level outside resources.
• Strong communication (both written and oral), facilitation, and presentation skills.
• Strong skill in working independently and to effectively interact with various levels of management
• Ability to lead and influence staff outside QA organization
• Able to manage performance issues and conflict
• Ability to evaluate documentation/ operations according to company and regulatory guidelines
• Ability to interpret and apply GMP, GLP, GCP, GPvP regulations
Preferred Qualification
• 5+ years’ experience in a regulated industry in a similar role (e.g. Biotechnology, Medical Device, Aerospace)
• Demonstrated strong Knowledge of industry and business principles
• Demonstrated strong problem-solving abilities and strong risk assessment capabilities
Education:
• Master’s degree in technical or related subjects and 3 years with direct experience
• Bachelor’s degree in technical or related subjects and 5 years with directly experience
• Will consider those that have significant years of direct experience in lieu of education requirements
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 54.00/daily.
Work Location: Remote
Assignment Duration: 06 Months
Work Schedule: PST hours preferred (EST hours okay) – Standard 8-5. Candidates may need to work outside normal business hours on occasion, particularly once per quarter for system releases.
Position Summary:
REMOTE: PST hours preferred (EST hours okay) - STANDARD 8-5. Candidates may need to work outside normal business hours on occasion, particularly once per quarter for system releases.
Ideal candidate: Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, and GCP regulations.
Key Responsibilities:
• Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
• Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
• Change Agent and advocate for the Risk Based Validation program
• Able to act as SME for multiple Quality processes (e.g. Deviations, CAPA)
• Review and Approve SOPs and associated documents
• Review/Approve Periodic Reviews for GxP Systems
• May perform software Supplier Evaluations as needed
• Support project initiatives, process improvements and or projects
• May be required to present on topics or issues to management
• May support audit & Inspections requests as needed
• May support other duties as required
Qualifications & Experience:
• Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
• Strong organizational skills, including ability to follow assignments through completion.
• Initiate and lead cross functional teams as needed
• Collaborate and communicate with higher level outside resources.
• Strong communication (both written and oral), facilitation, and presentation skills.
• Strong skill in working independently and to effectively interact with various levels of management
• Ability to lead and influence staff outside QA organization
• Able to manage performance issues and conflict
• Ability to evaluate documentation/ operations according to company and regulatory guidelines
• Ability to interpret and apply GMP, GLP, GCP, GPvP regulations
Preferred Qualification
• 5+ years’ experience in a regulated industry in a similar role (e.g. Biotechnology, Medical Device, Aerospace)
• Demonstrated strong Knowledge of industry and business principles
• Demonstrated strong problem-solving abilities and strong risk assessment capabilities
Education:
• Master’s degree in technical or related subjects and 3 years with direct experience
• Bachelor’s degree in technical or related subjects and 5 years with directly experience
• Will consider those that have significant years of direct experience in lieu of education requirements
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 54.00/daily.