Project Manager 1 - Quality Job

Requisition ID 14608BR
Title Project Manager 1 - Quality
Job Category Quality
Job Description Position Purpose:
Primary responsibility is to provide quality project management services. Scope of project may include computers, facility, utility, equipment and processes associated with the production of insulin products.
Quality project management includes the following activities:
•Providing technical input regarding requirements and design
•Developing time and resource estimates to complete projects
•Evaluate, select, and coordinate contract resources
•Review validation plans to ensure validation activities are in accordance with applicable FDA, EU and NN requirements
•Actively manage portfolio of projects and budgets to ensure projects are completed on time and on budget
Ensures systems developed for project are compliant with applicable regulations and company policies. Performs QA duties on the project, manages project quality resources and provides input to the project team on compliance.
Coordinates with QAFP and other departments in corrective actions and quality improvement initiatives related to the project.

Education: Bachelor's Degree in Life Sciences, Engineering, or related field or equivalent combination of education and experience.
Experience: 3-5 years of QA and/or related experience in pharmaceutical or medical device industry with progressively increasing responsibility including 3-5 years proven project management experience associated with packaging, assembly and facility systems.
Demonstrated expertise in Regulations and quality systems (e.g. product disposition, NC/CAPA, Change control, Audits, Validation, Sterile processing etc.)
Preferred: familiarity with local processes and quality systems
Technical/Process/Functional Knowledge:
? Demonstrated knowledge of critical controls and input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing, and process utilities.
?Expert knowledge of US, EU regulations and guidelines, ISO standards and application in GMP's in aseptic manufacturing
?Excellent written and verbal communication skills
?Basic computer skills in MS Office, MS Project, PowerPoint etc.
?Auditing experience with certification preferred

Physical / Other Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified.
Ability to accommodate extensive international travel. Ability to work in loud noise environments.
Ability to work hours necessary to support project, 24/7 production and /or maintenance activities.

Department QA Finished Production
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%