Product Support Associate in Portland, OR at Apex Life Sciences

Date Posted: 11/4/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Portland, OR
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/4/2018
  • Job ID:
    901250

Job Description


Apex Life Sciences is looking for  Product Support Associate for a biomedical client in Portland! Please see below and apply if interested!

Responsibilities:

  • Coordinate product testing internally and externally to ensure timely release of product.
  • Participate in CAPA, MRB, deviation reporting, NCR, and Customer Complaints.
  • Technical writing to document study plans and study results, validation plans and validation reports.
  • Perform laboratory testing to support product releases, investigations, and process improvement
  • Maintain and update product specifications.
  • Requests quotes, issues purchase orders and tracks receipt of goods/services related to job responsibilities within a defined budget.
  • Coordination of product bioburden and sterility testing, collection, and compiling of results for data review, and maintenance product sterility audit schedule and log.
  • Travel as needed (<15%) to support production troubleshooting, investigations, implementation of process change, etc.

Qualifications:

  • B.S. in a scientific discipline or equivalent experience. 
  • 0 - 5 years in an industry position requiring related scientific or technical experience.
  • 0 - 5 years in a medical device company or other FDA regulated industry preferred
  • Strong organizational skills required to collect and coordinate product testing information to support product release, investigations, and completion of validation reports, etc.
  • Excellent technical writing skills required. 
  • Strong analytical and communication skills a must.
  • Ability to work both independently (creative thinking, problem solving, design experiments) and work with others (good interpersonal skills). 
  • Knowledge/Experience in FDA Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) for medical devices, Design Control activities under 21 CFR 820 and ability to work under same routinely.
  • Strong computer skills which may include word processing, spreadsheet, and statistical software as may be required for an individual project.

Contact: Daniel | dyun@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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