Quality Associate III - Quality Systems

  • location: Research Triangle Park, NC
  • type: Contract
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job description

Quality Associate III - Quality Systems

job summary:
We have a 6 month renewable position for a Quality Associate III. Will IT Quality initiatives for a variety of systems including LIMS, Empower, Trackwise, Discoverant, MySims, Meridian. Must have a strong background with IT quality in a validated environment. Must have experience authoring quality documents from start to finish not just experience reviewing documents. Must have experience defining user requirements and experience with ALM planning documents. Must have experience with the SDLC.

The IQ Analyst supports the IT Quality department, team members and system development life cycle activities, including validation review and change control approval of IT systems. PRINCIPAL DUTIES & RESPONSIBILITIES: - Administer ITQ processes, manage team meetings and action register - Support ITQ team in the review of system life cycle deliverables and activities that ensure regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. III. JOB DEMANDS: This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to ITQ processes. The ITQ Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The ITQ Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven. IV. JOB IMPACT: The ITQ Analyst role provides a valuable service to ITQ, IT and Biogen in maintaining SDLC deliverables and systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices. IV. QUALIFICATIONS: - Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11,)regulations and guidelines - Experience performing Risk Assessments - Experience on Risk based validation approach - Experience validating SAAS solutions - Excellent communication skills, both verbal and written - Detailed knowledge on Data Integrity Requirements - Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment - Experience administering processes, scheduling and managing team meetings, and following up on action items - Experience with MS Word, Excel, Outlook and other business software programs - The ability to work both independently and with teams at various levels in the organization - Excellent organizational skills and attention to detail and accuracy - Seven or more years of experience in computerized system validation within a regulated environment - Experience working with ALM (HP), preferred.

 
location: Durham, North Carolina
job type: Contract
work hours: 9am to 6pm
education: Bachelors
 
responsibilities:
We have a 6 month renewable position for a Quality Associate III. Will IT Quality initiatives for a variety of systems including LIMS, Empower, Trackwise, Discoverant, MySims, Meridian. Must have a strong background with IT quality in a validated environment. Must have experience authoring quality documents from start to finish not just experience reviewing documents. Must have experience defining user requirements and experience with ALM planning documents. Must have experience with the SDLC.

The IQ Analyst supports the IT Quality department, team members and system development life cycle activities, including validation review and change control approval of IT systems. PRINCIPAL DUTIES & RESPONSIBILITIES: - Administer ITQ processes, manage team meetings and action register - Support ITQ team in the review of system life cycle deliverables and activities that ensure regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. III. JOB DEMANDS: This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to ITQ processes. The ITQ Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The ITQ Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven. IV. JOB IMPACT: The ITQ Analyst role provides a valuable service to ITQ, IT and Biogen in maintaining SDLC deliverables and systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices. IV. QUALIFICATIONS: - Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11,)regulations and guidelines - Experience performing Risk Assessments - Experience on Risk based validation approach - Experience validating SAAS solutions - Excellent communication skills, both verbal and written - Detailed knowledge on Data Integrity Requirements - Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment - Experience administering processes, scheduling and managing team meetings, and following up on action items - Experience with MS Word, Excel, Outlook and other business software programs - The ability to work both independently and with teams at various levels in the organization - Excellent organizational skills and attention to detail and accuracy - Seven or more years of experience in computerized system validation within a regulated environment - Experience working with ALM (HP), preferred.

 
qualifications:
We have a 6 month renewable position for a Quality Associate III. Will IT Quality initiatives for a variety of systems including LIMS, Empower, Trackwise, Discoverant, MySims, Meridian. Must have a strong background with IT quality in a validated environment. Must have experience authoring quality documents from start to finish not just experience reviewing documents. Must have experience defining user requirements and experience with ALM planning documents. Must have experience with the SDLC.

The IQ Analyst supports the IT Quality department, team members and system development life cycle activities, including validation review and change control approval of IT systems. PRINCIPAL DUTIES & RESPONSIBILITIES: - Administer ITQ processes, manage team meetings and action register - Support ITQ team in the review of system life cycle deliverables and activities that ensure regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. III. JOB DEMANDS: This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to ITQ processes. The ITQ Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The ITQ Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven. IV. JOB IMPACT: The ITQ Analyst role provides a valuable service to ITQ, IT and Biogen in maintaining SDLC deliverables and systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices. IV. QUALIFICATIONS: - Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11,)regulations and guidelines - Experience performing Risk Assessments - Experience on Risk based validation approach - Experience validating SAAS solutions - Excellent communication skills, both verbal and written - Detailed knowledge on Data Integrity Requirements - Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment - Experience administering processes, scheduling and managing team meetings, and following up on action items - Experience with MS Word, Excel, Outlook and other business software programs - The ability to work both independently and with teams at various levels in the organization - Excellent organizational skills and attention to detail and accuracy - Seven or more years of experience in computerized system validation within a regulated environment - Experience working with ALM (HP), preferred.

 
skills: We have a 6 month renewable position for a Quality Associate III. Will IT Quality initiatives for a variety of systems including LIMS, Empower, Trackwise, Discoverant, MySims, Meridian. Must have a strong background with IT quality in a validated environment. Must have experience authoring quality documents from start to finish not just experience reviewing documents. Must have experience defining user requirements and experience with ALM planning documents. Must have experience with the SDLC.

The IQ Analyst supports the IT Quality department, team members and system development life cycle activities, including validation review and change control approval of IT systems. PRINCIPAL DUTIES & RESPONSIBILITIES: - Administer ITQ processes, manage team meetings and action register - Support ITQ team in the review of system life cycle deliverables and activities that ensure regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. III. JOB DEMANDS: This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to ITQ processes. The ITQ Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The ITQ Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven. IV. JOB IMPACT: The ITQ Analyst role provides a valuable service to ITQ, IT and Biogen in maintaining SDLC deliverables and systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices. IV. QUALIFICATIONS: - Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11,)regulations and guidelines - Experience performing Risk Assessments - Experience on Risk based validation approach - Experience validating SAAS solutions - Excellent communication skills, both verbal and written - Detailed knowledge on Data Integrity Requirements - Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment - Experience administering processes, scheduling and managing team meetings, and following up on action items - Experience with MS Word, Excel, Outlook and other business software programs - The ability to work both independently and with teams at various levels in the organization - Excellent organizational skills and attention to detail and accuracy - Seven or more years of experience in computerized system validation within a regulated environment - Experience working with ALM (HP), preferred.


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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