QC System Specialist/Associate

AbbVie'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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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, or
• Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent
• Analytical thinking with Simple problem-solving and technical writing skills.
• Motivated and Independent.
• Basic GMP knowledge/Experience in laboratory
• Collaborator 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. 

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