Manufacturing Pharmaceutical Technician

Assignment Description :

Manufacturing Pharmaceutical Technician

(Granulation / Blend / Bead Coating)

Onsite - 2nd shift (4pm- 2 : 30am, M-Th)

Job Summary

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.

Primary 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.

Performs 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 manufacturing equipment (oral solid dose manufacturing may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines, etc.).

Perform in-process testing and inspections as required by Master Batch Record (weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.).

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. Follow 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.

Education and Experience 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.

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) pharmaceutical manufacturing Granulation / Blending and Bead Coating operations.

Supervisor Responsibilities (if applicable)

The Pharmaceutical Technician has no direct reports.

Additional Information / General / Organizational

Quality / Compliance : Achieve a standard of excellence with work processes and outcomes while maintaining compliance with policies and all regulatory requirements.

Communication : Clear, accurate, effective and timely written and verbal communication. Strong attention to detail and ability to write and record data legibly and accurately in accordance to cGMP regulations.

Teamwork / Collaboration : Work effectively with others to achieve goals, build strong working relationships and a positive work environment.

Critical thinking / problem solving : general ability to collect, organize and analyze data. Ability to recognize, analyze and solve a variety of problems.

Initiative : Ability to take ownership of work, doing what is needed without being asked and appropriate follow-through.

Adaptability : Being receptive to feedback, willingness to learn, and open to continuous improvement.

Operational Excellence : Embrace and support Operational Excellence Culture and Initiatives.

Accountability : Demonstrate ambition and discipline to achieve organizational and career goals

Availability : To work site schedule of 10.5 hours a day, Monday-Thursday and overtime as needed.

Physical and Environmental Requirements

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.

Ability to work a 10 hour per day / 4-day work week; 40 hours per week with overtime as required.

Assignment Description :

Manufacturing Pharmaceutical Technician

(Granulation / Blend / Bead Coating)

Onsite - 2nd shift (4pm- 2 : 30am, M-Th)

Job Summary

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.

Primary 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.

Performs 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 manufacturing equipment (oral solid dose manufacturing may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines, etc.).

Perform in-process testing and inspections as required by Master Batch Record (weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.).

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. Follow 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.

Education and Experience 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.

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) pharmaceutical manufacturing Granulation / Blending and Bead Coating operations.

Supervisor Responsibilities (if applicable)

The Pharmaceutical Technician has no direct reports.

Additional Information / General / Organizational

Quality / Compliance : Achieve a standard of excellence with work processes and outcomes while maintaining compliance with policies and all regulatory requirements.

Communication : Clear, accurate, effective and timely written and verbal communication. Strong attention to detail and ability to write and record data legibly and accurately in accordance to cGMP regulations.

Teamwork / Collaboration : Work effectively with others to achieve goals, build strong working relationships and a positive work environment.

Critical thinking / problem solving : general ability to collect, organize and analyze data. Ability to recognize, analyze and solve a variety of problems.

Initiative : Ability to take ownership of work, doing what is needed without being asked and appropriate follow-through.

Adaptability : Being receptive to feedback, willingness to learn, and open to continuous improvement.

Operational Excellence : Embrace and support Operational Excellence Culture and Initiatives.

Accountability : Demonstrate ambition and discipline to achieve organizational and career goals

Availability : To work site schedule of 10.5 hours a day, Monday-Thursday and overtime as needed.

Physical and Environmental Requirements

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.

Ability to work a 10 hour per day / 4-day work week; 40 hours per week with overtime as required.