Production Associate II

2 months ago

Torrance, United States Sakura Finetek USA Full time
Job DescriptionJob Description

General Position Summary

The Production Associate II role will perform a variety of routine filling assemblies & packaging operations for the GMP production of in-vitro diagnostic device products. These products include IHC, ISH, molecular, and immunochemical materials. The Production Associate II exercises independent judgement within authorized limits.

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.
  • Maintains work area in a clean, uncluttered, and safe manner.
  • Operates production machinery such as automated capsule sealer.
  • Verifies conformance to quality standards at all levels.
  • Performs autonomous maintenance activities such as PM on automated capsule filling machinery.
  • Delivers all released finished goods products to the designated inventory area in the warehouse.
  • Retrieves all released subassembly material from instrument production area.
  • Uses laboratory equipment such as pipettes, capsule sealer, filling pumps, and capsule cutter to meet the assembly requirements of each product.
  • Collaborates with Production Scientist to prioritize production needs.
  • Collaborates with interorganizational departments such as warehouse team and Instrument production team.
  • Assists with quarterly inventory cycle counts.
  • Fills appropriate quantity of reagents into in process containers and finished goods containers.
  • Inspects the quality of all materials and subassemblies prior to packaging.
  • Identifies quality issues, defects, and raises concerns to the attention of the Manager.
  • 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 and bartender.
  • Verifies accuracy and documents on production batch records.
  • Count capsules 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.
  • Cleans production areas and equipment
  • Performs raw material product and finished good product extensions.
  • Follows safety and quality standards.
  • Performs other duties and projects as assigned.

Clerical Activities

  • Completes Production Batch Records.
  • Checks and enters data. Performs WIP material transactions and product completion transactions in Oracle.
  • Assists in reviewing DHR for work order completion.
  • Handles photocopying, scanning and faxing.
  • Responsible for maintaining document filing systems.
  • Verifies that all delivered work orders from warehouse are properly labeled in the staging area.
  • Monitors, orders office supplies and maintains inventory.
  • Orders laboratory materials as needed.
  • Investigates and corrects discrepancies in reported quantities in SBS area locations.

Other Activities

  • Ensures correct products are being assembled in the correct packaging and pays attention to details.
  • 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.

Experience & Minimum Qualifications

  • 1-3 years’ experience in manufacturing or warehouse environment.
  • 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 use of email and internet.
  • Good numeracy skills.
  • Accurate keyboard skills
  • 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 to 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.

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