QC System SpecialistAssociate

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.

Qualifications :

• 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.

Additional Information :

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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time