Top Requirements Need
Job Summary
The Pharmaceutical Pkg. Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.
Primary Responsibilities
Follow Master Batch Records for the packaging of controlled, oral solid dose (OSD) and other dosage forms when required.
Perform weight checks for incoming and dispensed materials ensuring compliance with established procedures.
Operates scales including set-up, verification, leveling and challenging.
Identify, report, and resolve quality issues.
Safely and in compliance with batch records and SOPs, set up, operate, and clean packaging equipment.
Perform in-process testing and inspections as required by Master Batch Record (weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.).
Clean and sanitize packaging equipment including walls, floors, and ceilings per SOPs.
Report accidents and unsafe conditions or unusual circumstances to supervisor.
Complete accurate and timely documentation.
Follow good documentation practices in accordance with GMP.
Process labeling and components correctly; transferring, counting, FIFO, returns, etc. during packaging processes.
Actively participate in Production team and Site communication meetings.
Maintain regular and punctual attendance; work overtime as required.
Support GMP investigations and events.
Identify and report potential GMP impacting situations.
Contribute to Standard Operating Procedure (SOP) writing in your technical area.
Education And Experience Requirements
High School Diploma or equivalent.
Minimum of one five years pharmaceutical industry experience preferred or an equivalent combination of education, demonstrated mechanical skill, and experience in a similar industry.
Necessary Knowledge, Skills, And Abilities
General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division.
Understanding of the Metric System of Measurement.
Preferred experience in oral solid dose (OSD) pharmaceuticals in assigned process area.
Process areas include: Pharmacy/Dispensing, Granulation/Blending, Compression, Bead Coating, Extrusion, Encapsulation and Coating; Packaging with Serialization.
Physical And Environmental
Occasionally move/traverse, ascend/descend step ladders, stairs, and/or platforms.
Wear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator).
Occasionally, transport materials using manual, and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets.
Lift and maneuver empty drums weighing up to 40 pounds up to five times per day; push and maneuver drums containing product weighing up to 275 pounds up to five times per day.
Perform cleaning and assembly/disassembly on production equipment which may require pulling, pushing, or twisting to remove equipment shields, parts and panels. Equipment and parts may weigh up to 50 pounds.
ANY GRADUATE