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Quality Analyst

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Royal Biologics

2021-12-03 08:58:27

Job location Hackensack, New Jersey, United States

Job type: fulltime

Job industry: Science & Technology

Job description

POSITION SUMMARY:

Royal Biologics is seeking a Quality, Compliance, and/or Regulatory professional to support day to day functions of their Medical Device and Tissue manufacturing and distribution business. The Senior Quality Analyst will support a variety of functions including:

· Complaints

· Deviations/CAPAs

· Change Control

· Risk Management

· Document Management

· Lot Release

· Supplier Management (including participating in supplier audits)

· External Audit Support

· Training

· Validation

· Basic Regulatory Functions such as MDR reporting

· Process Trending

· Management Review Reporting

The candidate must be a self driven individual that can independently perform daily functions as per established procedures. They must also be able to independently improve existing processes and develop new processes when needed. Working knowledge of 21CFR820, 21CFR1271, 21CFR Part 11, ISO13485, and the AATB Standards of Tissue Banking are a plus, but are not required.

IDEAL CANDIDATE:

An ideal candidate has a minimum of 1-3 years within a Quality, Compliance, or Regulatory role within a Medical Device or Biologics company; however, recent graduates with a life science, chemistry, or engineering degree will also be considered. A candidate should possess the ability to think critically, have a passion for taking ownership in their work, and be able to balance a complex workload.

REQUIREMENTS:

· Bachelor's degree in a Life Science, Chemistry, or Engineering

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

COVID-19 considerations:
All employees are currently vaccinated with masks optional in the office except for visitors. Currently working limited days in the office.

Ability to commute/relocate:

  • Hackensack, NJ 07601: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

  • Do you have a Bachelor's degree in life sciences, chemistry, or engineering?

Education:

  • Bachelor's (Required)

Work Location: One location

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