Description:
Perform repetitive tasks by dispensing, labeling, and assembling components and subassemblies to create medical diagnostics kits. Create component labels, test set labels and Instructions For Use (IFU’S) for medical diagnostics kits and contract manufacturing. .

ESSENTIAL FUNCTIONS, included but not limited to:

• Read and follow Standard Operation Procedure (SOPs) and Packaging Instructions (PIs) to build medical diagnostic kits to specifications.
• Generate component and test set labels from the label generation form once sample label has been approved.
• Create labels from scratch for other departments following SOP’s, when requested.
• Print Instructions For Use (IFU’S) from the IFU/Addendum Release and Accountability Form once sample has been approved; if required, cut and/or fold.
• Before start of assignment and during each step of production process, obtain Line clearance verification from the Production Lead or Designee.
• Verify production kit numbers, lot numbers, and expiration dates are printed accurately, and batch integrity is maintained.
• Obtain a sign-off of all completed paperwork where required during each step of the production process from the Production Lead or Designee.
• Follow process for filling liquids by reading pick list, documenting means of dispensing and equipment used, calibrating machines, recording weights, and capping, torquing and/or leak testing per SOPs.
• Adhere approved labels to filled components via automated machine or manually in accordance with SOP.
• Assemble components following packaging instructions (PIs); label test set boxes, folding Instructions for Use (IFU), etc.; Reference PIs for step-by-step procedures/photos of process and kit layout.
• Shrink wrap and/or Quality Seal finished assembled kits per customer requirements.
• Identify concerns or discrepancies with all paperwork and quality; communicate situation with urgency to Production Lead, Production Supervisor or Production Manager, when necessary.
• Clean workstation at the completion of each assignment.
• Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.).

REQUIRED QUALIFICATIONS:

• High School Diploma or its equivalent.
• Legally authorized to work in the United States.

PREFERRED QUALIFICATIONS:

• Assembly line or Production line experience.
• Demonstrated ability to read and follow SOPs and assembly instructions.
• Experience in a cGMP or regulated environment.
• Working knowledge of Microsoft Word and Outlook.
• Familiar with EZLabel software or similar.

BASIC SKILLS AND ABILITIES:

• Detail oriented, accurate, efficient, and accountable.
• Proven ability to meet deadlines; work in a fast-paced environment.
• Ability to work independently and as a member of various teams and committees.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Project a positive company image by interacting with fellow employees, and/or management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Good typing skills for accurate keystrokes in data entry.
• Ability to operate related office equipment, such as computer, calculator, and copier.

REASONING ABILITIES:

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

LANGUAGE SKILLS:

• Ability to read and interpret work related documents, procedures, and manuals.
• Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language.

MATHEMATICAL SKILLS:

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents.

• Read and follow Standard Operation Procedure (SOPs) and Packaging Instructions (PIs) to build medical diagnostic kits to specifications.
• Generate component and test set labels from the label generation form once sample label has been approved.
• Create labels from scratch for other departments following SOP’s, when requested.
• Print Instructions For Use (IFU’S) from the IFU/Addendum Release and Accountability Form once sample has been approved; if required, cut and/or fold.
• Before start of assignment and during each step of production process, obtain Line clearance verification from the Production Lead or Designee.
• Verify production kit numbers, lot numbers, and expiration dates are printed accurately, and batch integrity is maintained.
• Obtain a sign-off of all completed paperwork where required during each step of the production process from the Production Lead or Designee.
• Follow process for filling liquids by reading pick list, documenting means of dispensing and equipment used, calibrating machines, recording weights, and capping, torquing and/or leak testing per SOPs.
• Adhere approved labels to filled components via automated machine or manually in accordance with SOP.
• Assemble components following packaging instructions (PIs); label test set boxes, folding Instructions for Use (IFU), etc.; Reference PIs for step-by-step procedures/photos of process and kit layout.
• Shrink wrap and/or Quality Seal finished assembled kits per customer requirements.
• Identify concerns or discrepancies with all paperwork and quality; communicate situation with urgency to Production Lead, Production Supervisor or Production Manager, when necessary.
• Clean workstation at the completion of each assignment.
• Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.)