Job Description

Company DescriptionAbbVie\'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 . Follow @abbvie on , , , and .Purpose

• Responsible for leading the coordination of all activities associated with release testing on finished API and incoming raw material testing and In-process control samples for chemical and biological molecules.
• Ensure adherence to cGMP\'s and corporate and site procedures as well as regulatory compliance.
• Support Lab Supervisor and Lab Manager.

Responsibilities

• Plan resources to support all routine and non-routine sample testing.
• Responsible for capacity planning of QC lab. Ensure all testing is carried out in a timely and efficient manner to meet release leadtime and site metrics.
• Coordinate the timing of method technology transfer activities and work closely with members of MS&T Analytical and Site Tech Center and support general project activities.
• Introduce Lean principles such as FIFO and 5S.
• Review any method transfer or method qualification reports or equipment qualifications. Provide oversight on lab equipment calibration and maintenance program.
• Co-ordinates New Product Introduction (Small molecule or Biologic product) to enable a successful / timely program launch.
• Initiate Lab investigations and ensure all CAPAs are implemented in time and effectively.
• Create or review documentation work i.e. protocols, SOP\'s, lab change control, etc.
• Support audit preparation and audit responses, including the development and implementation of programs to provide timely follow up on correctives and commitments.
• Assist in planning QC budget.
• Lead and drive CI initiatives and laboratory performance metrics. Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Any other tasks as and when assigned by Supervisors.

Qualifications

• Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree.
• Minimum 5 years of pharmaceutical experience in an analytical testing environment within Quality department and with demonstrated organizing competency. Candidates with more years of experience will be considered for the Senior Planner role.
• Strong GMP background.
• Strong analytical mind with good problem solving and writing skills.
• Highly motivated and independent.
• Possess strong interpersonal and communication skills, with ability to work within cross-functional teams.
• Organized and result-oriented.
• Ability to work under pressures.

Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie\'s 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 protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

AbbVie