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QMS Compliance Analyst

Nutra-Med Packaging
locationHanover, NJ, USA
PublishedPublished: 6/14/2022
Technology
Full Time

Job Description

Job DescriptionQMS Compliance Analyst

Do you excel at translating regulations into practical, day-to-day quality practices? Can you thrive in a high-speed, 24/7 environment while juggling audits, investigations, and training records? If so, you’ll feel right at home here. This role reports to the Senior Manager of Regulatory Compliance and serves as a linchpin across QA.

What will you tackle?

  • Are you ready to co-own site compliance, identify program gaps, and partner with QA to close them swiftly?
  • Could you coordinate internal, client, and regulatory audits—scheduling, hosting, and ensuring CAPAs land on time?
  • Will you keep our QMS sharp by updating SOPs/policies, processing change controls, managing documents, and logging/maintaining training records?
  • Do you grasp 21 CFR Parts 111, 210, 211, and 820 and how to ensure alignment with client and company standards?
  • Can you investigate issues to root cause, build sound CAPAs, and maintain complaint-handling rigor?
  • Are you comfortable analyzing quality metrics, spotting trends, and escalating critical signals to leadership?
  • Will you support regulatory and client inspections with confident, compliant documentation?
  • Can you pivot quickly amid changing priorities and still contribute to continuous improvement?
  • Will you assist with Document Control and support Batch Record creation, review, and release, along with general QA needs?

What you bring

  • Minimum B.S. degree or 2–5 years of QA experience in a regulated industry.
  • Hands-on experience conducting quality system assessments for manufacturing/packaging sites and suppliers; knowledge of packaging systems.
  • Computer savvy across spreadsheets, databases, and word processing; ERP exposure is beneficial.
  • Strong written and verbal communication; able to coach peers and stakeholders to meet Nutra-Med SOPs.

Equal Opportunity

Nutra-Med Packaging, LLC., is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. We make hiring decisions based solely on qualifications, merit, and business needs at the time.

Ready to contribute?

If answering “yes” to the questions above felt natural, we invite you to apply and help strengthen our QMS every day.

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