AbbVie Biologics Production Supervisor in Barceloneta, Puerto Rico
Biologics Production Supervisor
USA, Puerto Rico, Barceloneta
Manufacturing & Operations
The Biologics Production Supervisor is that function which supervises the Third (3rd) Shift personnel in any of the areas of Humira BDS Manufacturing Area (Inoculum. Fermentation, Capture, Purification or Central Services Operations). It's main objective is to work accordingly to quality standards at the most economical cost on-time according to established production schedule. Provides supervision to any of the BDS Manufacturing Areas. In order to meet Plant throughput, maintaining the quality, cost and manpower utilization; keeping the manufacturing variances and the cost reduction plans within established goals and achieving efficiency optimization for the Plant's financial goals and support the division sales plan. Anticipate and issue action plans to avoid situations that affect the operating and environmental conditions for the people and the equipment. Assure that necessary resources are provided of the operations in order to get maximum efficiency.
Must have a creative, versatile and analytical mind to resolve manufacturing related problems to promote and maintain a high level of quality competence and motivation in the ABL Plant. Should have a high degree of initiative and responsibility which would enable incumbent to perform efficiency with minimum of supervision. Using all knowledge plus the inputs from supporting Departments, must reach immediate decisions when problems arise which are affecting the output or quality of the product being produced. Must also assure that corrective action is taken in order that said situations area avoided and reduced to the minimum.
Include the essential duties and/or responsibilities of the position. Each essential function must support the objective of the job.
Responsible to plan and control the manufacturing operation to meet Plant throughput, maintaining cost and manpower utilization per established expectations.
Supervision and training of the non-exempt personnel assigned within BDS Manufacturing Operations.
Assure compliance with applicable regulatory agencies.
Anticipate and correct situations that affect the operating and environmental conditions for the people and the equipment.
Assure proper verification of the materials to be used for the production activities.
Responsible to comply with Abbvie Policies and ABL Plant procedures, Regulatory Agencies and Safety and Environmental Regulations.
Responsible of the execution, audit and correction on time of the manufacturing electronic batch record discrepancies.
Assure that deviations from approved procedures are properly and promptly documented and investigated.
Develop and implement corrective actions in timely manner to prevent deviation recurrence.
Assure that manufacturing facilities and equipment are maintained in proper conditions.
Coordinate activities with all support areas such as: Maintenance, Warehouse, Laboratories, Utilities, Manufacturing, Science & Technology, and Quality Assurance to maintain continuity and efficiency of the operations.
Assure that Labor Law’s requirements are followed.
Provides and maintains the required manual and electronic documentation (SOP's, batch records, etc.) and information concerning the activity of the area including; personnel, and production.
Provide assistance to operations in the control, management and disposal of household wastes, biomedical and hazardous to their respective area as applicable, ensuring compliance with federal and local regulations and policies following plant, division and corporate procedures.
Maintain a Healthy working environment in the area of responsibility.
Responsible of performing the direct reports performance evaluations (goal setting performance evaluations).
Provide technical assistance to the manufacturing areas. Assist in the troubleshooting of the manufacturing equipment's and process issues.
Investigate process and equipment exceptions and follow up CAPA implementation.
Revise SOP's and PCR's and submit Change Requests (CR) for approval.
Develop and implement changes that will improve equipment performance and consequently product quality and reduce manufacturing costs.
Initiate capital project ideas dealing with safety, quality improvement, capacity increase and or cost reduction.
Participate in the development and execution of Validation Protocols, Process Control Systems and MES changes.
Assure the manufacturing facilities and equipment are maintained in proper conditions.
Work in a clean aseptic environment.
Must wear gowning appropriate to the area classification on a daily basis.
Direct 0 10
Indirect 0 0
Accountable for the profitable operation of the portion of business on a continuing basis. Must gain the cooperation not only of subordinates, but also of other departments and support personnel upon whom must rely.
Provide interpretation of policies and procedures.
Exercise responsibility and authority to hire, transfer, suspend, recall, promote, discharge, assign, discipline and recommend compensation changes.
Help subordinates to understand their duties and responsibilities review and appraise the qualifications and performance of subordinates against established goals.
Promote harmony among subordinates.
Create an atmosphere which will encourage truthfulness and openness of communication.
Manage personnel using a participative approach.
Involve subordinates in decisions that affect them.
Work as back-up for supervisors from other manufacturing areas.
Assist in establishing and assuring the observation of safety and cGMP Practices.
Minimum of 5 years of experience in the health care industry, manufacturing environment of a biotechnological, pharmaceutical or chemical plant in all aspects of manufacturing/production process
Minimum 2 years of Supervisory experience in a manufacturing related area in a health care industry.
Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA Regulations) knowledge of corporate, local state and OSHA regulation.
Skills to operate computer automated systems and computer programs knowledge (Power Point, Excel, and Microsoft Words).
Good delegation skills.
Excellent interpersonal skills and people management also, teamwork oriented to interact with other departments and to maintain a highly motivated work force.
Skills to read, write and understand technical information in English and Spanish.
Problem solving abilities.
Capable of working with multiple tasks and deadlines with minimum supervision.
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced
Job Level Code: IC