2nd Shift Production Supervisor

Aphena Pharma Solutions•Easton, MD

139d•$60,000 - $65,000•Onsite

About The Position

Aphena Pharma Solutions is looking for a 2nd Shift Production Supervisor to join our team in Easton, MD! This role involves overseeing production operations, ensuring product quality, managing personnel, and maintaining documentation in compliance with cGMP and ISO regulations.

Requirements

High school diploma required.
Three years of cGMP supervisory experience preferred.
Ability to analyze problems and present solutions
Ability to direct and supervise employees
Ability to be open-minded to all views and decisions
Knowledge of cGMP and ISO Regulations
Understanding of inventory counting, lot control and accountability
Proficient in basic math skills
Proficient in Microsoft Word and Microsoft Excel
Great documentation practices including use of proper grammar.
Receive instructions through oral and written communications.
Convey answers or instructions to other employees.
Able to lift and move materials up to 40 pounds.
May be exposed to noise, chemicals, perfumes, fumes and odors.
Will be exposed to inside and outside environmental conditions.
The physical activity of this activity of this position includes, but is not limited to: Climbing, walking, stooping, kneeling, crouching, reaching, standing, pushing, pulling, lifting, grasping, twisting, sitting, and feeling.
Safety equipment will be provided where needed and required to be worn.

Nice To Haves

Completion of supervisory seminars a plus.

Responsibilities

Initiate and accurately prepare MBR’s in a timely manner in accordance with the production plan.
Determine the correct lot code/expiration code for each work order assigned.
Initiate label requests for each work order and perform first piece approval with QA.
Accurately execute each MBR to ensure product quality.
Perform finished product first piece approval for each new work order.
Ensure that all required retain samples have been taken per the MBR.
Maintain, label and store retains as required.
Work closely with the Quality Team in order to ensure product quality, calculate and verify sampling plans, and ensure dual signature verification as required per the MBR.
Work closely with the Inventory Control Department to ensure adequate materials are available at each work center as needed for product manufacturing as well as other items needed for the production floor such as cleaning materials, gowning supplies, etc.
Coordinate with the Inventory Control Department with concerns in relations to all hazardous waste and label each container properly.
Coordinate with the sanitization crew as to what isolation rooms are to be sanitized each week.
Challenge work centers to improve outputs and decrease labor.
Submit change controls as needed to accurately reflect component usage per work center.
Submit change controls as needed for work instruction, SOP, and MBR changes as needed.
Determine cleaning requirements for new and existing products.
Write and update change controls as needed for cleaning procedures.
Review all change controls for assigned work stations and product specific Work Instructions.
Supervise and train all personnel that are assigned to shift/area and maintain accurate training records.
Schedule all assigned employees based on production needs.
Ensure/train all new employees on work stations per documented instructions.
Ensure/train material handlers to accurately supply all production lines as required as well as maintaining a clean facility.
Evaluate staff, write annual reviews and discuss with employees.
Maintain current work center and facility documentation as required.
Review and execute OQ, PPQ production runs.
Maintain and document all necessary documentation involved.
Review OQ and PPQ reports for final signature approval.
Create and review for accuracy all paper work that applies to the equipment that is running on appropriate shift.
Accurately assign labor per employee, per work station, per shift in order to ensure correct production statistic entry.
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.
Work closely with Production Support Department to recognize and correct any and all machinery problems.
Work closely with Production Support and Product Planner to schedule appropriate Preventive Maintenance when downtime on a machine is needed.
Segregate and document non-conforming product.
Report any unsafe acts or accidents to the Safety Manager.
Report/document any accidents or human resource issues to the Human Resource Department and Production Manager and assist in all investigations of such.
Handle/document all disciplinary issues as they arise.
Inform the Production Manager and HR of all disciplinary issues.
Oversee/perform line clearance activities.
Maintain a clean and orderly work area to comply with 5S standards.
Perform/assist in kaizen events.
Work hours as needed to support the production schedule. Overtime may be required.
Cross train on all work centers as time permits.
Assist with CAPA’s that pertain to the area of responsibility.
Post accurate WO information to ensure that all employees assigned to the work center are aware of the lot code for the work order.
Work closely with Manager of Production in all areas listed above.