Requisition ID 17562BR
Title Quality Systems Project Area Specialist
Job Category Quality
Job Description Position Purpose:
Primary responsibility is to provide quality system project support and/or management.
Quality project management and support includes the following activities:
• Leading and/or participation in projects related to Quality Systems and Documentation Management implementation and/or changes (Note: Some projects may require both project leadership as well as participation)
• Evaluate, select, and coordinate resources as required
• Actively manages project portfolios (i.e. PPM) and budgets to ensure projects are completed on time and on budget
• Effectively collaborate with cross-functional Project Teams (i.e. from HQ) in order to ensure effective and timely implementation of Quality Systems.
Responsibilities also include ensuring local quality processes are in compliance with cross-functional requirements as well as regulatory requirements. Accepts ownership of and ensures local quality processes are clearly described in a LEAN manner. Works closely with quality process stakeholders to ensure that the QMS functions well within the organization.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field.
Experience:
5 years of QA and/or related experience in pharmaceutical or medical device industry with progressively increasing responsibility
2+ years of project management experience (preferred projects associated with the implementation of Quality Systems)
Demonstrated expertise in pharmaceutical or medical device regulations and quality systems (e.g. nonconformity handling, CAPA implementation, Change Control, Quality Management Review, etc.)
Technical/Process/Functional Knowledge:
Expertise in non-capital, small to medium project management.
Expert knowledge of US, EU regulations and guidelines, ISO standards and application in GMP’s in aseptic manufacturing
Functional knowledge of Pharmaceutical Quality Systems
Excellent written and verbal communication skills
Basic computer skills in MS Office, MS Project, PowerPoint etc.
Expert ability in the use of MS Excel including its use in tracking, trending and reporting data.
Functional knowledge of VBA
Physical / Other Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to accommodate international travel. Ability to work in open office environment.
Ability to work hours necessary to support projects and aggressive timelines.
Department Quality Systems Management and Support
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Quality Systems Project Area Specialist
Job Category Quality
Job Description Position Purpose:
Primary responsibility is to provide quality system project support and/or management.
Quality project management and support includes the following activities:
• Leading and/or participation in projects related to Quality Systems and Documentation Management implementation and/or changes (Note: Some projects may require both project leadership as well as participation)
• Evaluate, select, and coordinate resources as required
• Actively manages project portfolios (i.e. PPM) and budgets to ensure projects are completed on time and on budget
• Effectively collaborate with cross-functional Project Teams (i.e. from HQ) in order to ensure effective and timely implementation of Quality Systems.
Responsibilities also include ensuring local quality processes are in compliance with cross-functional requirements as well as regulatory requirements. Accepts ownership of and ensures local quality processes are clearly described in a LEAN manner. Works closely with quality process stakeholders to ensure that the QMS functions well within the organization.
Education: Bachelor’s Degree in Life Sciences, Engineering, or related field.
Experience:
5 years of QA and/or related experience in pharmaceutical or medical device industry with progressively increasing responsibility
2+ years of project management experience (preferred projects associated with the implementation of Quality Systems)
Demonstrated expertise in pharmaceutical or medical device regulations and quality systems (e.g. nonconformity handling, CAPA implementation, Change Control, Quality Management Review, etc.)
Technical/Process/Functional Knowledge:
Expertise in non-capital, small to medium project management.
Expert knowledge of US, EU regulations and guidelines, ISO standards and application in GMP’s in aseptic manufacturing
Functional knowledge of Pharmaceutical Quality Systems
Excellent written and verbal communication skills
Basic computer skills in MS Office, MS Project, PowerPoint etc.
Expert ability in the use of MS Excel including its use in tracking, trending and reporting data.
Functional knowledge of VBA
Physical / Other Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to accommodate international travel. Ability to work in open office environment.
Ability to work hours necessary to support projects and aggressive timelines.
Department Quality Systems Management and Support
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%