Pharma Quality & GMP Compliance Specialist

Eurofins PSS Insourcing Solutions

New York (NY)

On-site

USD 55,000 - 62,000

Full time

2 days ago
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Benefits offered by this job

Medical, dental, vision insurance
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Bonus potential

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a QA professional to establish quality metrics aligned with standards and oversee data collection, investigations, and reporting across GMP environments.

You will collaborate with cross-functional teams, manage quality improvement activities, and ensure adherence to GMP/FDA regulations while supporting daily operations and training programs.

Qualifications

  • Bachelor’s degree with 2+ years in QA or related field, or Master’s with 1 year in science.
  • Experience in quality investigations, deviations, audits, CAPAs, quality management systems, controlled document storage, etc.
  • Pharmaceutical industry experience.
  • Strong knowledge of global regulatory and cGMP requirements.
  • Experience with manufacturing operations.
  • Strong technical writing ability.

Responsibilities

  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Demonstrates and promotes the company's vision
  • Regular attendance and punctuality
  • Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
  • Coordinate workflow and perform daily monitoring to meet TAT
  • Perform and/or assign other duties as requested to ensure the smooth operations of department

Skills

Quality investigations
CAPAs
Quality management systems
Controlled document storage
Regulatory knowledge
Technical writing

Education

Bachelor’s + 2 years or Master’s +1 year in science

Job description

Eurofins USA PSS Insourcing Solutions is seeking a QA professional to establish quality metrics aligned with standards and oversee data collection, investigations, and reporting across GMP environments.

You will collaborate with cross-functional teams, manage quality improvement activities, and ensure adherence to GMP/FDA regulations while supporting daily operations and training programs.

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