Perform quality control analysis, prepare reagent samples using basic laboratory equipment
Effectively perform a multitude of laboratory techniques for which they are trained on with minimal error area to improve efficiency
Reviewer and verifications of assays, data and records
Maintain integrity, accuracy and completeness of QC data and records
Ensure accurate data generation and entry of records into LIMS system
Timely escalate to relevant stakeholders to ensure samples are tested and released on time
Involve in incident investigation and reporting
Ensure compliance with cGMP, Quality, work safety instructions & practice at all times
Identify and support Out-of Specification (OOS), Out-of-Trend (OOT) deviations and quality problems of raw material and products (IP/Release) testing
Participate in monitoring and inspecting laboratory infrastructure, equipment and utilities
Responsible in inventory management
Responsible in routine calibration and maintenance of laboratory equipment
Assist in method transfer or method validation protocols or equipment qualifications and support transfer of new products
Training of new personnel on compendia or simple instrument method
Identify opportunities and assist with the implementation of procedures, process and / or workflow within own work
Any other responsibilities or tasks as assigned by your Supervisor / Manager
Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree
At least 1-3 years relevant experience depending on qualification, preferably in the bio-pharmaceutical / Pharmaceutical industry
Good working knowledge of cGMP and regulatory requirements related to Quality is preferred
Problem-solving and troubleshooting skills.
Highly motivated and independent.
Possess good interpersonal and communication skills.
Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance\xe2\x80\x99s and industry standards for analytical development and characterization.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie\xe2\x80\x99s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person\xe2\x80\x99s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
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