Job Summary
Generalist position that supports the Quality Systems department’s overall needs.
Job Details
This position is responsible for the following:
· Responsible for the compilation and analysis of data required to support Annual product reviews, which includes, but is not limited to revisions to Product Specifications, Manufacturing and QC Master Records; Final Release Inspection results; Stability results; GTW records, and Product Complaint information etc.
· Responsible for the preparation of annual product review reports according to product schedule.
· Assist with the compilation and analysis of data for Quality metrics for the site to support Quality Management review meetings at the site and Quarterly Corporate Segment review meetings.
· Assists with review and approval of site metrics and data for PI meetings.
· Assist with performing of Internal audits in adherence with the annual Internal audit schedule.
· Provide support to the front and or back room during site audits and inspections as needed.
· Assisting with Duties in Quality Documentation Group – including but not limited to maintaining and facilitating the review and approval of controlled documents such as SOP’s, Master Records, project documents etc.
maintenance of controlled document storage, issuance, retrieval and maintenance of logbooks.
· Perform other duties as assigned.
Education and Experience:
Minimum requirements for this position are:
Education - Bachelor’s Degree in a science or related field preferred, or equivalent combination of education and experience required.
Experience - Three (3) to five (5) years of experience in a laboratory or quality role
Experience: Systems - Advanced Microsoft Office
Experience: Regulatory - Experience in a regulated environment preferred
Experience: Aseptic - Experience in the manufacture of pharmaceuticals
Essential Knowledge, Skills & Abilities:
· Excellent analytical and problem-solving skills; ability to analyze data.
· Excellent oral and written communication skills.
· Technical writing skills and trouble shooting skills.
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Ability to work effectively with peers and supervisors.
· Working knowledge of cGMP’s and QA systems.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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