Senior Analyst, Quality Control

• Conduct chemical and physical laboratory tests and analyze excipients cleaning samples raw materials
• intermediates and final products including protocol testing in a timely manner to ensure compliance with standards and production targets.
• Conduct verification of testing records and all associated electronic and hardcopy documentation.
• Compile datapacks along with generation of Final CoA as necessary.
• Receiving of samples into the QC Laboratory through LIMS.
• Recognize and report to immediate supervisor any issues or deviations from accepted standards.
• Provide status updates on own activities and productivity challenges according to defined procedures.
• Ensuring that analysts working in the assigned team are performing to the best of their ability coaching and providing guidance where issues occur such as poor set-up or test execution performance.
• Improving the overall efficiency and velocity within the assigned team.
• Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
• Acting as designee for the QC Supervisor as assigned.
• Acting as the primary point of contact for any analytical issues which arise.
• Supporting & initiating analytical OOS issues as they arise in a timely manner through practical work.
• Maintain data integrity and ensure compliance with FDA GLP QSR and cGMP regulations as well as with company SOPs and specifications.
• Complete and conform to all training requirements for job role including company-required and job role-specific training.
• Author documents that ensure cGMP compliance such as laboratory investigation deviations change controls change notices analytical test methods; analytical test method development reports; method validation protocols; method transfer protocols and reports; method verifications protocols and reports; and instrumentation qualification documentation (URS/IQ/OQ/PQ).
• Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
• Conforming to the safety culture on site on Zero Believe it Achieve it.
• Instilling the safety culture of Zero Believe it Achieve it amongst the QC laboratory team
• Participate in the 6S activities within the QC Laboratory.
• Positively contribute to departmental goals and programs such as Right First Time
• Developing expertise and understanding of current and future analytical techniques.

Qualifications :

• 3rd level qualification in a relevant Science discipline.
• Desired minimum 4 years analytical experience in the pharmaceutical industry
• Experience in pharmaceutical manufacturing facility.
• Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
• Proven track record in an analytical role. Must be expert in common analytical instrumentation e.g. HPLC Dissolution GC FTIR Electro Chemistry (DME) UV/Vis and other USP instrumental and Wet chemistry technologies used in pharmaceutical Quality Control Laboratory.
• Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.
• Demonstrated success in making effective and persuasive presentations on complex topics to upper management.

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