Full-Time

QA/RA Specialist I

Posted on 4/27/2024

KMA Human Resources Consulting

KMA Human Resources Consulting

51-200 employees

HR consulting and talent management services

Consulting

Mid, Senior

Biddeford, ME, USA

Required Skills
Quality Assurance (QA)
Requirements
  • Bachelor of Science degree in Life Sciences
  • 5+ years of employment in a cGMP regulated facility
  • 2+ years of experience in Quality Assurance/Regulatory Affairs
  • Must be a nonsmoker
  • Vaccinations for Covid required
  • Knowledge of current GMP regulations
  • Knowledge of ISO 13485
  • Strong skill in utilizing Microsoft Office software
  • Excellent proof-reading skills
  • Experience in laboratory medicine
  • Good communication skills
  • Technical writing skills
  • Ability to meet challenging timelines
  • Willingness to learn and pitch in as part of team
  • Capable of rapidly developing sufficient expertise to function independently
Responsibilities
  • Activities involving quality assurance and compliance with regulatory requirements
  • Maintaining policies and procedures for quality compliance
  • Documenting Quality System documentation
  • Supporting and documenting MRNs and CAPAs
  • Performing internal and supplier audits
  • Supporting regulatory and customer audits
  • Assisting in the assembly of Device Master Records
  • Maintaining training documentation of employees

KMA Human Resources Consulting

KMA Human Resources Consulting

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KMA Human Resources Consulting offers professional HR consulting, recruiting, and compensation services, specializing in compliance, employee development, and talent management for businesses in New England.

Company Stage

N/A

Total Funding

N/A

Headquarters

Falmouth, Maine

Founded

2007

Growth & Insights
Headcount

6 month growth

-8%

1 year growth

-9%

2 year growth

-10%