About AbbVie 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. Job Summary Supervises the daily operations of a manufacturing area ensures that all department operations are accomplished in compliance with cGMP/ISO regulations, as well as meeting production standards. Job Details The expectations of responsibilities for this position are the following: Administrative Job Task- Time card management, personnel coaching, development, responsible for conducting 1:1 with employees, driving and sustaining an inclusive culture, supervise the daily activities of employees by providing training, direction, guidance, counseling or disciplinary action when necessary, and, in conjunction with HR, makes decisions regarding personnel actions (to include but not limited to hiring, terminations, promotions). Schedule Management - Responsible for adhering to manufacturing production schedule Material Management – Expected to ensure all necessary components / resources are available and capable to meet production schedule and established quality standards and goals. Record Corrections - Responsible for ensuring record corrections are complete in a timely manner not to impact release of product Quality System Management – to include but not limited to CAPA Investigations/LIRs and Internal Audit Observations. FMS Management – Responsible for managing FMS as defined per applicable SOP’s Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. Perform all assigned duties according to departmental SOP’s and cGMP’s. Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department Perform additional tasks as required to support the production of product to provide on-time delivery to customers. Assist daily production in operating and monitoring technical, computerized, production machinery, ensuring quality standards are maintained. Obtain aseptic gowning certification and ensure all employees follow aseptic technique. 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 Qualifications Education and Experience: Minimum requirements for this position are: Education Bachelor’s Degree in Business or related field. Experience: Supervisory Two (2) years of experience in supervision. Experience: Certifications Green Belt certification or ability to become certified. Experience: BT Systems Proficient in Microsoft Word, Excel, and SAP. Experience: Regulatory Experience working in a GMP regulated environment preferred. Experience: Aseptic Experience working in an Aseptic Production environment preferred. Essential Knowledge, Skills & Abilities: Knowledge and application of fundamental concepts of manufacturing, including CGMP/QSR. Analytical and problem-solving skills. Ability to communicate effectively (verbal, written and presentation skills). Ability to work effectively with peers and supervisors. Analytical and problem-solving skills. Demonstrated managerial ability. Excellent organization skills. Detail oriented and the ability to manage multiple task. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. Proficiency in Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Ability to work any shift (up to 12-hours) as required dependent on business needs. Physically able to continuously stand and walk. Physically able to lift up to 40 lbs. for men and 35 lbs. for women. Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently. Significant Work Activities Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC 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.