Manufacturing Associate II

2 weeks ago

Torrance, California, United States Sakura Finetek USA Full time
Job Overview

Position Summary

The Manufacturing Associate II position involves executing a range of routine assembly and packaging tasks essential for the GMP production of in-vitro diagnostic device products. This includes working with IHC, ISH, molecular, and immunochemical materials. The Manufacturing Associate II is expected to exercise independent judgment within established parameters.

Key Responsibilities

Production Duties

  • Conducts various tasks requiring expertise in assembly and packaging methods for IVD products.
  • Assembles all Tissue Tek Genie and Genemed product line materials and finished items.
  • Keeps the workspace organized, clean, and safe.
  • Operates production machinery, including automated capsule sealers.
  • Ensures compliance with quality standards throughout the production process.
  • Performs routine maintenance on automated capsule filling equipment.
  • Transfers all approved finished goods to the designated inventory area.
  • Retrieves approved subassembly materials from the production area.
  • Utilizes laboratory tools such as pipettes, capsule sealers, filling pumps, and capsule cutters to fulfill assembly requirements.
  • Collaborates with Production Scientists to prioritize production tasks.
  • Works with various departments, including warehouse and instrument production teams.
  • Assists in quarterly inventory counts.
  • Accurately fills required quantities of reagents into containers.
  • Inspects the quality of all materials and subassemblies before packaging.
  • Identifies quality concerns and communicates them to management.
  • Prepares components, packaging inserts, and other materials.
  • Assembles, labels, and packages product components and finished goods.
  • Pulls subassembly products and compiles components into kits.
  • Prints labels using approved templates.
  • Verifies accuracy and documents information on production records.
  • Counts products consistently and accurately.
  • Follows verbal or written instructions from supervisors.
  • Adheres to Standard Operating Procedures (SOPs) to meet product specifications.
  • Cleans production areas and equipment.
  • Handles raw material and finished product extensions.
  • Complies with safety and quality regulations.
  • Performs additional duties as assigned.

Administrative Responsibilities

  • Completes Production Batch Records.
  • Enters data and performs material transactions in the system.
  • Assists in reviewing documentation for work order completion.
  • Handles administrative tasks such as photocopying and filing.
  • Maintains document filing systems.
  • Ensures all delivered work orders are correctly labeled.
  • Monitors and orders office supplies.
  • Orders laboratory materials as necessary.
  • Investigates and resolves discrepancies in reported quantities.

Additional Responsibilities

  • Ensures correct assembly and packaging of products, focusing on detail.
  • Documents activities for management review.
  • Evaluates and suggests improvements in methods and procedures.
  • Seeks continuous improvement in work processes.
  • Maintains an orderly and functional workspace.
  • Communicates effectively within the organization.
  • Participates in team meetings as required.
  • Performs other duties as directed by management.

Essential Qualifications

Education

High school diploma, GED, or equivalent experience.

Experience & Skills

  • 1-3 years of experience in a manufacturing or warehouse setting.
  • Ability to work effectively under pressure while maintaining quality.
  • Strong interpersonal skills.
  • Capable of working independently or collaboratively.
  • Adaptable to changes and quick to learn new procedures.
  • Proficient in email and internet usage.
  • Good numerical skills.
  • Accurate typing skills.
  • Ability to follow written and verbal instructions.
  • Familiarity with FDA Good Manufacturing Practices (GMP).
  • Ability to meet deadlines.

Physical Requirements & Work Environment

  • Ability to work safely with laboratory equipment.
  • Capability to lift and move up to 50 lbs.
  • Requires prolonged standing or sitting, with frequent bending and stretching.
  • Ability to manage multiple work pressures.
  • Effective verbal communication skills.
  • Ability to listen and assist 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 outlines the essential functions and skills required for this position. These responsibilities are not exhaustive and may be subject to change at the company's discretion.

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