Job Description

Company DescriptionAbbVie\'s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\'s lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .PurposeThe primary function is to support management of all QC laboratory systems (E.g.: Equipment, LIMS, CDS, IT related systems), participate in method technology transfer, participate in laboratory equipment technological refresh or introduction is in adherence to cGMP regulatory compliance and corporate/site procedures expectation.Responsibilities

• Supports team task to enable adequate resources to support laboratory infrastructure (E.g.: Equipment, Method, System) needs.
• Participates in the management of laboratory equipment and IT systems in QC laboratory to ensure business continuity and system data maintenance, equipment maintenance/calibration is in a state of compliance.
• Participates in method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline.
• Participates in QC laboratory long range planning to ensure laboratory infrastructure needs is secured and Data integrity plan is in place to support business and laboratory compliance.
• Author method transfer/qualification and equipment qualification documentation (E.g.: Reports, Protocol, change control, related quality documents or procedures) are in cGMP compliance to corporate/site or regulatory requirements.
• Supports and ensure timely escalation/handling of lab events or related quality actions. (E.g.: NCR, Lab Investigation, CAPA)
• Supports preparation and participate in internal/external audit, audit responses, to enable a successful audit outcome.
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Lead/supports CI initiatives to enable laboratory performance metrics.
• Carry out any other task as assigned by Supervisor.

QualificationsEducation:

• University Degree in Science related discipline (E.g.: Chemistry, biology, pharmaceutical Sciences, or equivalent experiences).

Experience:

• Minimum 1 - 3 years of pharmaceutical experience in a Quality Control Function.
• Experienced in Regulatory/ Pharmaceutical requirements.

Skills:

• Analytical thinking with basic problem solving and writing skills.
• Motivated and independent.
• Basic GMP knowledge/Experience on QC Lab Equipment and Method transfer.
• Good communication skills and strong ability to work cross functional teams.
• Ability to work towards timeline.

Additional InformationAbbVie is an equal opportunity employer and 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.US & Puerto Rico only - to learn more, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

AbbVie