Manufacturing Technician II, Compounding (7pm - 7am)

Company: AbbVie
Location: Waco
Posted on: January 22, 2023

Job Description:

Job Summary Responsible for compounding high-quality solutions, semi-solids, and suspensions in accordance with Good Manufacturing Practices (GMP) and department Standard Operating Procedures (SOP). Job Details This position is responsible for the following:

• Accurate formulation of products.
• Stage, load, operate, and monitor all equipment for product formulations.
• Weighing and mixing chemicals according to specific formulas.
• Calibrate, operate, and monitor all formulation-related equipment (e.g., mixers, scales, meters, etc.).
• Perform operations necessary to adjust the pH of product for in-process testing.
• Clean, steam, and sanitizes all tanks, facilities, equipment and chemical containers used in the product formulation process in accordance with current SOPs and cGMPs.
• Accurately complete documents and record production volumes (batches) in compliance with current GDP standards.
• Assumes other duties and responsibilities, as necessary, within the Compounding department, in an effort to provide the required support to ensure adherence to the production schedule. 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. Education and Experience: Minimum requirements for this position are: Education High School Diploma or GED equivalent. Associates Degree preferred with coursework in the Sciences. Experience: Technical At least two (2) years related work experience, preferably in a high-speed production or manufacturing environment. Experience: Regulatory Experience working in a GMP regulated environment preferred. Experience: Systems Basic user knowledge of Microsoft Office, SAP experience preferred. Experience: Aseptic Experience working in an Aseptic Production environment preferred. Essential Knowledge, Skills & Abilities:
• Ability to perform detailed tasks and document activities completely and accurately.
• Ability to think and plan in a logical sequential order.
• Able to work in a controlled environment that includes surgical mask and goggles.
• Ability to comply with gowning validation and subsequent gowning verifications.
• Ability to work any shift (up to 12-hours) as required dependent on business needs.
• Capable of standing for long periods of time. Capable of using hands to feel objects, use tools or controls and reach with hands and arms.
• Ability to read, comprehend, write, and communicate effectively in English.
• Ability to carry out detailed written or oral instructions.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Basic user knowledge and understanding of Windows-based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
• 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. Work Environment
• Frequently works with hot water and steam.
• Frequently walks on slippery or uneven surfaces.
• May handle and transport Hazardous and Non-Hazardous material.
• May climb stairs or use ladders and work off elevated surfaces on an occasional basis during each shift.
• Noise level in the work environment is frequently loud but managed below the acceptable OSHA regulated level. Principal Accountabilities Percent indicated is the average time spent on a task and will vary depending on the workflow. % Time Task # Description of Task 40% 1. Responsible for the compounding activities of manufacturing solutions, semi-solids, and suspensions, including weighing, bulking, sterile filtration, steam sterilization, sanitization, and documentation activities associated with the manufacturing. Sets up, inspect, and operate equipment to process sterile solutions. Utilize aseptic techniques to maintain product sterility. Report process deviations to supervisor to prevent product deviations. Comply with cGMP rules and procedures. 25% 2. Maintain, complete, and review all production documentation including batch records, logbooks, sterilization records, and weighing documentation. Identifies and prevents possible sources of non-compliance in the area. Maintains the manufacturing area housekeeping to current standards. Assists in performing preventative maintenance activities. 10% 3. Prepares all equipment for production by performing cleaning and sanitization duties. Inspects all equipment and facilities prior to use. Assists in performing preventative maintenance. 10% 4. Ensures proper accountability of raw materials. Coordinates and ensure all expired raw materials are removed from the manufacturing areas. 5% 5. Assists in the performance of Compounding and Validation projects assigned by Department Management. 5% 6. Actively participate in departmental meetings and contribute to the achievement of the following Department performance indicators: *Adherence to the Production Schedule. *Reduction of batch errors and deviations, *Consistent compliance with cGMPs by avoiding significant cGMP violations and successful FDA audits with no major observations. 5% 7. Satisfactory performance in complying with all safety rules and procedures, effective contribution in identifying and preventing accidents and unsafe working conditions. Individual participation in meeting the accident frequency goal. At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the companys affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.

Keywords: AbbVie, Waco , Manufacturing Technician II, Compounding (7pm - 7am), Professions , Waco, Texas