Senior Analyst, Quality Control

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

• 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 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