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Operations Associate

Employer
Aziyo Biologics, Inc.
Location
Roswell, GA
Start date
Jan 12, 2023

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Job Details

Company Overview

 

Aziyo Biologics, Inc. is a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, concentrating on patients receiving implantable medical devices. Since its founding in 2015, the Company has created a portfolio of commercial-stage products used in cardiovascular, orthopedic, and reconstructive specialties.

 

Position Overview

This position is responsible for performing a variety of repetitive and non-repetitive or unique assembly operations for Aziyo products including, but not limited to, receiving, receiving inspection, shipping, inventory control, manufacturing activities as well as environmental monitoring & maintenance. The responsible individual will perform routine data entry in the MRP database, LHR releases, preparation of international shipping documentation, etc. in compliance with internal procedures, FDA quality systems regulations as well as ISO standards.

Position reports to the Senior Director, Operations & Engineering.

Essential Duties & Responsibilities

Production:

  • Issue, track, and review Manufacturing Work Order (LHR) documentation for accuracy and component/product traceability.
  • Assemble products according to approved operating procedures.
  • Perform label printing and final packaging as required to support operations functions.
  • Perform self-inspection on all assembly work performed to ensure adherence to workmanship standards.
  • Maintain clean and orderly workstation.
  • Follow all corporate, safety and production operating procedures.
  • Perform environmental monitoring including viable & non-viable particulate counting, surface microbial testing as well as review and analysis of data for each test cycle.
  • Other duties as required.

Inventory & Distribution:

  • Process incoming receiving and inventory transactions in the MRP system.
  • Process transactions and documentation associated with product returns.
  • Perform periodic cycle counting to monitor inventory levels and report inventory balances for financial reconciliation.

Receiving Inspection:

  • Prepare and review inspection documentation and perform inspections as needed.

Distribution:

  • Prepare international shipments with appropriate documentation in compliance with all applicable export requirements.

Education

  • High School Diploma or equivalent.

Experience and Skills

  • 1 – 2 years’ experience in manufacturing and/or quality (production, packaging, labeling incoming and shipping, critical systems, etc.) preferred.
  • Experience working in regulated work environment preferred – compliance to specifications and procedures as well as FDA QSR’s (21 CFR 820) and ISO 13485.
  • Basic computer skills.
  • Must be a self-starter and demonstrate a commitment to process improvement.
  • Ability to exercise judgement, problem solve and work well with cross-functional teams.
  • Excellent organizational skills.
  • Service oriented with meticulous attention to detail.
  • Works well under pressure with strict deadlines.

Physical Requirements

  • Must have the ability to lift 65 lbs. or more.
  • Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
  • Ability to distinguish colors

For more information, please visit aziyo.com. 

 

We are an equal opportunity employer committed to affirmative action and diversity in our workforce – M/F/D/V

Company


Aziyo Biologics was created by HighCape Partners and Tissue Banks International with the mission of restoring health and mobility to the greatest number of patients. Our vision is to impact healthcare through innovation of new solutions that expand the possibilities of regenerative medicine.

YEAR FOUNDED:

2016

LEADERSHIP:

Executive Chairman & Interim CEO: Kevin Rakin

COO: Michelle LeRoux William, PhD

VP, Technical Services: Erica Elchin


PRODUCTS

Please click here for Aziyo Biologics' products.

Company info
Website
Phone
855-416-0596
Location
880 Harbour Way S
Suite 100
Richmond
California
94804
US

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