AbbVie Laboratory Technician VI at AbbVie supporting pharmaceutical manufacturing chemistry lab operations. Responsible for stability testing, investigations, and compliance with GMP and regulatory standards.
Responsibilities
Provides technical support to Chemistry Laboratory staff in executing stability protocols and conducting testing. Supports laboratory operations and manufacturing activities related to raw materials, in-process materials, and finished products.
Conducts investigations on out of specification test results.
Organizes and may perform testing of raw materials (including USP water), bulk samples, and finished product to assure the chemical quality of the product.
Evaluates stability of raw materials, bulk samples, and finished product per established protocols.
Interfaces with QA counterparts to optimize laboratory support of QA and production activities.
Works effectively with chemists to complete special sample analyses as required.
Preforms other duties as assigned and assists on special projects as required.
The incumbent is empowered to make decisions and take actions necessary to fulfill job responsibilities. The role requires compliance with applicable ethics, environmental health and safety, financial, human resources, cGMP, and general business policies, requirements, and objectives. The incumbent must also be willing to accept temporary assignments as needed.
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Bachelor’s Degree with an emphasis in Chemical or related science.
5 years of experience in pharmaceutical manufacturing chemistry lab or similar laboratory experience.
Qualification
Strong math skillsAbility to readExperience with LIMS and Trackwise
Required
Experience working in an aseptic environment preferred.
Excellent analytical skills and problem-solving skills.
Strong math skills, including the comprehension of metric weights and measures, performing complex calculations, and spreadsheet management.
Ability to perform detailed tasks and document activities accurately.
Able to work in an aseptic controlled environment which includes wearing PPE, aseptic gowning qualifications, and subsequent gowning requalification’s.
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts).
Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
Ability to read, comprehend, write, and communicate effectively in English.
Intermediate user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Experience with SAP preferred.
