General Position Summary

The Associate Production Technician I performs a wide range of tasks in the production process, and primarily supports critical reagent line by filling assemblies & packaging finished goods for the GMP production of in-vitro diagnostic device products. This position works closely with SBS Associate Scientists, Associate Production Technicians, Production Associates, QC, QA, Procurement, and Warehouse teams to produce high-quality IHC, ISH, molecular and immunochemical products to support the Tissue-Tek Genie and Genemed brands.

Responsible for operating and supporting the troubleshooting process of highly complex, high throughput Automated Capsule Machine. Performs set-up and operation of production equipment. Under supervision, inspects, cleans, and maintains production equipment. Monitors and inspects output to ensure products adhere to specifications and company's quality standards.

Essential Job Functions

Production Activities

• Performs various tasks requiring knowledge of assembly and packaging techniques for IVD products.
• Assembles all Tissue Tek Genie and Genemed product line stock materials and finished goods.
• Skillful in the use of the custom-made Automated Capsule Machine with adept knowledge of the operation of the machine.
• Resolve minor issues involving the equipment to ensure SBS production operations run efficiently.
• Proficient in the operation of the Filamatic pump to support various Tissue Tek Genie products.
• Competent in the use of the manual capsule machine and capsule cutter.
• Operates, monitors, and maintains labeling equipment.
• Assists in the manufacturing equipment maintenance activities.
• With general supervision, troubleshoots and resolves routine production issues on the floor including but not limited to production equipment while ensuring design integrity, product quality, and delivery timelines.
• Assists with training new hires on SBS filling, assembly, and packaging processes.
• Supports activities for all production equipment related to filling and packaging.
• Determines which equipment will run orders based on set parameters.
• Delivers all released finished goods products to the designated inventory area in the warehouse.
• Retrieves all released subassembly material from instrument production area.
• Skilled in the use of laboratory equipment such as pipettes.
• Collaborates with SBS Associate Scientists to prioritize production needs.
• Collaborates with interorganizational departments such as Warehouse, Procurement, Manufacturing and Engineering.
• Support Associate Production Technicians and Production Associates with quarterly inventory cycle counts
• Assist with the management of all stock withdraw transactions.
• Inspects the quality of all materials and subassemblies prior to packaging.
• Identifies quality issues, defects, and raises concerns to the attention of the Supervisor.
• Prepares components, bottles, package inserts, boxes, and others.
• Assembles, labels, and packages product components, in-process materials, and finished goods.
• Pulls subassembly products and assembles components into kits.
• Prints labels using approved label templates from Agile, NiceLabel, and Bartender.
• Verifies accuracy on production batch records.
• Verifies capsule counts and other products accurately and consistently.
• Works from verbal or written instructions from Supervisor.
• Follows Standard Operating Procedures (SOP's), guidelines and/or diagrams to ensure product specifications are met.
• Performs raw material product and finished good product extensions.
• Implements safety and quality standards.
• Verifies conformance to quality standards at all levels.
• Maintains work area in a clean, uncluttered, and safe manner.
• Performs other duties and projects as assigned.

Clerical Activities

• Completes Production Batch Records.
• Verifies and enters data. Performs WIP material transactions and product completion transactions in Oracle Fusion.
• Assists in reviewing DHR for work order completion.
• Photocopies, scans, and faxes documents as necessary.
• Responsible for maintaining document filing systems.
• Ensures that all delivered work orders from warehouse are properly labeled on the staging area.
• Monitors and orders inventory of office supplies.
• Orders laboratory materials to ensure efficient workflow.
• Investigates and corrects discrepancies in reported quantities in SBS area locations.

Other Activities

• Pay close attention to detail to ensure correct products are being assembled in the correct packaging.
• Documents activities for management review.
• Evaluates and recommends changes in methods and procedures in assigned area of responsibility.
• Seeks constant improvement in work processes and techniques.
• Assures that assembly and final packaging areas are in an orderly and functional condition.
• Suggests improvement in departmental work processes and procedures.
• Maintains good communications both inside and outside of the Company.
• Attends and participates in group meetings as needed.
• Performs other duties and projects as assigned by Company Management.

Essential Job Requirements

Education

High school diploma, GED or equivalent education and experience.

Associate degree preferred.

Experience & Minimum Qualifications

• 0 - 3 years' experience in manufacturing or related work environment or equivalent combination of education and work experience.
• Ability to work well under pressure and time constraints while maintaining a high level of work quality.
• Excellent interpersonal skills.
• Ability to work independently or as part of a team.
• Adaptable to change and able to learn new procedures and techniques.
• Proficient in the use of email and the internet.
• Good numeracy skills.
• Accurate keyboard skills.
• Able to perform basic mathematical equations and formulas.
• Ability to use hand tools and be able to do repetitive work.
• Ability to apply common sense to carry out instructions in written and verbal forms.
• Ability to comply with FDA Good Manufacturing Practices (GMP).
• Ability to meet project deadlines.

Physical Requirements & Working Environment

• Ability to work safely and according to departmental procedures when working with simple laboratory equipment.
• Ability to lift and or move up to 50 lbs.
• Requires prolonged standing or sitting, frequent bending, stooping, and stretching.
• Ability to successfully respond to multiple work pressures.
• Ability to communicate verbally with individuals and groups.
• Ability to communicate verbally in person and using a phone.
• Ability to listen for understanding and assisting in problem solving.

"Sakura Finetek USA, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law."

The above description identifies the essential job functions and skills needed by the person or persons assigned to this position. These job functions and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the company's discretion.