Supervisor, Quality Laboratories
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Oversees any of Environmental Monitoring, Product Testing or Site Aseptic Processing Simulation Programs. Coordinates and supports method validations and prepares Laboratory / validation reports. This position requires thorough scientific knowledge and technical expertise, technical writing, investigation experience, problem solving and strong regulatory knowledge (FDA/CFR/ISO/USP/EP).
This position is responsible for the following:
- Receiving and interpreting the results of microbiological testing for aseptic simulation, raw material, bulk and finished products and environmental and utility monitoring.
- Investigating out of specification conditions and implementing corrective action.
- Reviewing and approving laboratory testing documentation.
- Coordinating testing release with the final Quality Control records.
- Preparing monthly laboratory reports in conjunction with the microbiology manager.
- Ensuring that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget.
- Ensuring that SOP’s align with regulator expectations, are updated and are available to all laboratory personnel.
- Ensuring that all laboratory employees meet training requirements and work to ensure that the company is in compliance with all regulatory, environmental, health and safety requirements. This is performed in conjunction with ensuring that our business practices enhance the welfare of our customers, employees and the community in which we operate.
- Reviewing current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.
- Any additional tasks/projects as assigned by the laboratory manager.
- This person may serve as a back-up when the Micro Lab Manager is unavailable.
- When required, support supplier audits/appraisals, internal, and regulatory audits.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.Regulated Responsibilities (including cGMP and EHS)
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.
Minimum requirements for this position are:
Bachelor’s Degree in Microbiology or related Science.
Knowledge of microbiology, environmental monitoring and regulatory requirements with minimum of five (5) years of industrial microbiology with emphasis in the pharmaceutical and/or medical device industry, or equivalent experience
Experience: BT Systems
MS Office (Word, Excel, PowerPoint), SAP, QMS/Trackwise (preferred), Johnson Controls/FMS (preferred), MODA (preferred).
Experience working in a GMP regulated environment.Essential Knowledge, Skills & Abilities:
- Experience performing and validating microbiological methods
- Excellent analytical and problem-solving skills
- Ability to understand, use and author technical documents
- Excellent written documentation skills (Fluent in English)
- Proven ability to work effectively with others
- Good oral and written communication skills (Fluent in English)
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.