Blending Supervisor

Aphena Pharma Solutions Md - Easton, MD

Full-time - Mid Level

Easton, MD

Chemical Manufacturing

About the position

The Blending Supervisor at Aphena Pharma Solutions-MD, LLC is responsible for overseeing the blending operations, ensuring compliance with quality standards, and leading a team of blenders. This role involves creating work instructions, initiating master batch records, and coordinating with various departments to ensure efficient production processes. The supervisor will also be involved in training staff, maintaining safety standards, and implementing continuous improvement initiatives.

Responsibilities

• Create cleaning work instructions for blending with input from other departments.
• Challenge current blending processes and look for continuous improvement and cost savings.
• Modify Master Batch Records (MBRs) and Work Instructions as needed following the proper Aphena SOP.
• Initiate and accurately prepare master batch records (MBR) in a timely manner in accordance with the production plan.
• Lead the blending area and be present and hands on for all new product launches.
• Assist in coordinating with Production Scheduling and Inventory Control to ensure materials are available as needed.
• Ensure cleaning, sanitization and batch records are accurately executed to ensure product quality.
• Review completed blend batch records to ensure compliance prior to submitting the completed batch records to the QC Department.
• Review daily blending activities are logged into Blending Activity, PM, and Set Up Log Books for all Blending Work Centers, Pharmacy and Sample room.
• Ensure weekly sanitization is performed in Blending, Pharmacy and Sample Room.
• Ensure that blend samples submitted to the lab for testing are properly labeled.
• Review new business blending opportunities and provide input for blending processes.
• Assist with evaluation of handling, pre-weighing and transferring new raw materials to ensure safety of blending personnel.
• Assist with manufacturing investigations as needed.
• Ability to use and understand blending software.
• Train other employees to become blenders.
• Ensure all training records for the blenders are up-to-date.
• Evaluate staff and discuss performance reviews as required.
• Fill in as a blender as needed.
• Maintain efficient outputs and be able to anticipate problems and be prepared to discuss and evaluate problems, which have prevented meeting set standards and outputs.
• Ensure that setup and preventive maintenance are performed as required.
• Work closely with Production Support Department to recognize and correct any and all machinery problems.
• Training and performing basic analytical lab testing, testing blends for pH when required.
• Schedule staff based on production needs.
• Report any unsafe acts or accidents to the Safety Manager.
• Report/document any accidents or human resource issues to the Human Resource Department and the Director of Operations and assist in all investigations of such.
• Accurately complete assays from master batch record to perform pre-weigh adjustments based on the CoA (Certificate of Analysis) from analytical lab.
• To be able to meet requirements to handle Controlled Substances including pre-weighing and charging component to blend vessels.
• Work closely with Human Resources and the Director of Operations on disciplinary issues as they arise.
• Responsible for maintaining orderly and clean blending work areas.
• Work hours as needed to support the production schedule. Actual shift schedules may vary.
• Train and assist with Controlled Substances including receiving, storage, pre-weighing and charging component to blend vessels.
• Assist with varied tasks as needed.
• Assist and work closely with department representatives to perform Risk Assessments, PSAs (Process Safety Analysis), PHAs (Process Hazard Analysis) as needed.
• Train and assist the handling and proper disposal of hazardous materials including addressing minor drips and spills.

Requirements

• High school diploma required.
• At least 3 years of blending experience.
• Ability to read, understand, and follow instructions and material safety data sheets.
• Ability to train and fully understand proper handling of hazardous waste, storing, labeling, per RCRA regulations.
• Fully understanding USP water spec limits for various locations samples are taken to ensure testing results are acceptable.
• Fully understanding the general concept of cleaning and sanitization and testing required to ensure proper procedures are implemented and followed.
• Skilled in utilizing and understanding measuring equipment, blending software, pH meter, temperature charts and gauges.
• Skilled in using required material handling equipment such as forklifts and pallet jacks, various pumps.
• Excellent math skills including understanding unit of measure conversions and complex equations for determining API additions to blends based on API incoming assay.
• Strong documentation skills, understand HMI, understand HMIS labeling, basic mechanical operational skills, environment safety training and hazardous chemical handling training.

Nice-to-haves

• Knowledge of cGMP and ISO Regulations.
• Ability to analyze problems and present solutions.
• Ability to direct and supervise employees.