Manufacturing Technician IV, Compounding, A2 shift
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.
Responsible for compounding high-quality solutions, semi-solids, emulsions, and suspensions in accordance with Good Manufacturing Practices (GMP) and department Standard Operating Procedures (SOP).
The expectations of responsibilities for this position are the following:
- Line Turn Management – Responsible for ensuring line turns are performed on time according to the standards set in place for each specific line.
- First point of contact - responsible for initial communication of issues on production line to ensure proper urgency is taken for resolution. Expectation is to escalate immediately in the event the issue cannot be resolved.
- Cover the areas during breaks - Responsible for ensuring on time manufacturing at the highest optimal level by covering breaks and lunches as necessary.
- Role Delegation - Responsible for assignment of duties/activities performed on the line
- Material Management - Responsible for managing materials needed on shift ensuring no downtime due to components not readily available and material loss.
- Documentation Verification - Responsible for verification of documentation required for current and next run on production line. Ensuring the document is the current effective document needed for production.
- On the Shop Floor – Expectation to be present 90% of the time on the floor
- FMS Management - Responsible for ensuring FMS is acknowledged and proper steps are taken in the event of an excursion per applicable SOP guidance.
- 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.
- Minor equipment troubleshooting as needed.
- Perform real time document review, facilitate labor by coordinating/ facilitating breaks, product manufacturing, and line turns.
- Stage, load, operate, and monitor all equipment for product formulations.
- Ability to perform Weighing and mixing chemicals according to specific formulation as directed by applicable process procedures and SOP’s.
- 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 SOP’s and cGMP’s.
- Ensure sterile product transfer to filling departments.
- Accurately complete documents and record production volumes (batches) in compliance with current GDP standards.
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:
High School Diploma or GED equivalent and/or Associate’s Degree with eight (8) years of Abbvie Compounding experience and proficiency in four (4) compounding process. OR, B.S. in the Sciences preferred and proficiency in three (3) years Compounding Experience.
Experience working in a GMP regulated environment preferred.
Basic user knowledge of Microsoft Office and SAP. Advanced Microsoft Office and SAP user experience preferred.
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 conduct employee training on compounding process according to SOPs and GMPs.
- 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.
- Advanced user knowledge of Microsoft Office and SAP, 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.
Percent indicated is the average time spent on a task and will vary depending on the workflow.
Description of Task
Responsible for the compounding activities of manufacturing solutions, emulsions, 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.
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.
Train employees on Compounding tasks and procedures.
Ensures proper accountability of raw materials. Coordinates and ensures all expired raw materials are removed from the manufacturing areas. Coordinate and ensure cycle counts are performed. Maintains inventory of supplies and materials used in manufacturing area in coordination with the Supervisor.
Update Manufacturing Procedures and departmental SOP’s. Provide training to ensure all full-time and temporary personnel comply with all SOP’s, cGMP’s, FDA regulations, and safety guidelines.
Assists Lead Compounders and Supervisors with investigations of deviations and assists in audits and inspections as needed.
Performs and oversees Compounding and Validation projects assigned by Department Management.
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.
Contributes to the achievement of the following Department performance indicators:
*Adherence to the Production Schedule.
*Reduction of batch errors and deviations,
*Consistent compliance with cGMP’s by avoiding cGMP violations, and successful FDA audits with no major observations.
Actively participate in departmental meetings and contribute to the overall effectiveness of the team.
- 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.
Significant Work Activities
Continuous standing 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.