Role Summary
Performs light inspection and/or a limited number of manual and/or automated manufacturing support functions. Performs verification of defects for development of defect kits. This may include line clearance, outfeed/accumulation, scale operation, overwrap, carton/casing, canning, labeling, capping stoppering, and equipment/machine cleaning and sanitation in compliance with SOPs, cGMPs, batch records, TCPs, BOMs and POPs.
Take the lead on supporting/facilitating On-the-Job-Training process signoffs for new and existing colleagues and contractors. Serve as a back-up for Group Leader when absent and support SAP transactions.
Responsibilities
- Support and provide feedback to new and existing colleagues and contractors on requirements for work area.
- Under the guidance of management, must be able to step in intermittently for Group Leader or APL to meet operational goals.
- If Group Leader/APL is not available, serves as point of contact for questions and guidance pertaining to running the line, production, and compliance and final accountability for packaged material and product for area of operations.
- Support SAP transactions as needed for area of operation, order, schedule and consume commodities, send commodities out and finalize process orders.
- Responsible for escalating personnel behavior and performance concerns to supervisor.
- Serve as a subject matter expert in room procedures and operations.
- Operate Dabricoβs, labelers, canning, casers, overwraps, checkweighers, cartoners and other machinery per assigned room.
- Ensure product quality during the production process.
- Perform line clearances and verify filter MITβs.
- Pull and deliver QC samples.
- Check in cages and warehouse materials.
- Perform in-process pH testing for fill lines and volume testing/leak tests.
- Prepare documentation of sterilization and daily tags.
- Notify Group Leader/Supervisor of all safety issues.
- Maintain proper documentation β batch records, check sheets, logbooks.
- Ensure preventative maintenance is current.
- Perform all tasks in a safe manner and stay current with training requirements.
- Perform room and equipment sanitation; equipment/machine cleaning and basic sanitation.
- Ensure adherence to all plant safety rules in area of responsibility.
Qualifications
- High school diploma or equivalent (GED)
- Minimum of 6 months in a Pfizer Pharmaceutical Assistant role.
- Completed or willing to complete Certified Trainer course.
- Able to make minor mechanical machine adjustments.
- Must be self-motivated, with a problem-solving mindset.
- Ability to work effectively both independently and as a part of a team.
- When assigned to a fill line must be aseptically trained.
- Must be able to communicate and work well interdepartmentally, as well as, with all plant departments.
- Must be able to read and write, as well as follow written and oral instructions.
Additional Requirements
- Frequent lifting of 15-20 pounds and occasional lifting in excess of 25 pounds.
- Vision must be correctable to 20/20.
- Must be able to withstand exposure to inks, solvents and liquids.
- Stand for 8 to 12 hours depending on assigned area.
- Must be able to push, pull and/or lift above shoulders.
- Push and pull heavy carts or tanks.
- Hours are 6pm-6am operating on an A/B schedule. Ability to work overtime as needed.
- Work Location: On Premise.