Pharmaceutical Formulation Technician
Axelon Services Corporation
Wilson, NC
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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Current Good Manufacturing Practice (cGMP), Detail Oriented, Disassemblers, Dosage Forms, Drug Manufacturing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), High School Diploma, Industrial Coating, Lift/Move 40 Pounds, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing/Industrial Processes, Material Moving, Mathematics, Metrics, Pallet Jack, Problem Solving Skills, Procedure Development, Regulations, Standard Operating Procedures (SOP), Team Player, Technical Writing, Testing, United States Drug Enforcement Agency (DEA), Writing Skills
LOCATION
Wilson, NC
POSTED
14 days ago
Summary:
- Efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.
Responsibilities:
- Follow Master Batch Records for the manufacturing of controlled, oral solid dose (OSD) and other dosage forms when required.
- Prepare raw materials, blends, and bulk accountability throughout manufacturing processes.
- Perform weight checks for incoming and dispensed materials ensuring compliance with established procedures.
- Operate scales including set-up, verification, leveling, and challenging.
- Identify, report, and resolve quality issues.
- Set up, operate, and clean manufacturing equipment safely and in compliance with batch records and SOPs.
- Perform in-process testing and inspections as required by Master Batch Record.
- Clean and sanitize manufacturing rooms including walls, floors, and ceilings per SOPs.
- Report accidents and unsafe conditions or unusual circumstances to supervisor.
- Complete accurate and timely documentation following good documentation practices in accordance with GMP.
- 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.
Requirements:
- High School Diploma or equivalent.
- Up to three years pharmaceutical industry experience preferred or an equivalent combination of education, demonstrated mechanical skill, and experience in a similar industry.
Required Skills:
- General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division.
- Understanding of the Metric System of Measurement.
- Strong attention to detail and ability to write and record data legibly and accurately in accordance with cGMP regulations.
- Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.
Preferred Skills:
- Experience in oral solid dose (OSD) pharmaceutical manufacturing Granulation/Blending and Bead Coating operations.
Benefits:
- 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.
About the Company
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