About this role
The 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:
Team Support
• Responsible for supporting QC laboratory infrastructure/system needs (e.g. Equipment, Method, QC
Systems) for routine usage.
• Develops technical competency and jointly creates a great place to work in.
Financial Support
• Supports financial spending are within the latest best estimates.
• Supports QC infrastructure/technological needs through long range plan execution.
Compliance (Quality and Safety)
• Develops to be SME for QC Operational readiness (E.g.: QC system or method transfer),
infrastructure/instrumentation (E.g.: Advance technology) and compliance readiness (Eg: QC System, Lab
compliance, Data integrity) per cGMP/EHS/Regulatory compliance global or site procedures expectations.
• Authors lab documentation, method transfer/qualification and equipment qualification (E.g.: Reports, Protocol,
change control, related quality documents or procedures) are in cGMP compliance to corporate/site or
regulatory requirements.
• Participates or supports in resolution of laboratory investigation/exception or actions for closure.
• Participates in internal/external audits and enables audit response for a successful outcome in sustaining
licenses to operate.
Infrastructure & Instrumentation
• Supports 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.
• Supports QC laboratory long range plan to ensure laboratory infrastructure needs is secured and Data
integrity plan is in place to support business and laboratory compliance.
New Product Introduction, Projects & Continuous Improvement
• Supports method technology transfer and infrastructure/laboratory equipment technological introduction
activities into QC Laboratory within project timeline.
• Supports CI initiatives to enable laboratory performance metric.
• Any other task/projects assigned by line manager.
Bachelors in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, orEngineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalentAnalytical thinking with Simple problem-solving and technical writing skills.Motivated and Independent.Basic GMP knowledge/Experience in laboratoryCollaborator with cross functional teams.Able to work towards timeline.Minimum 2 years for Bachelor graduate with relevant work experience in Biotechnology / Pharmaceutical industry is preferred. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html