Nutraceutical QA Lead & Compliance Coordinator

US Pharma Lab

North Brunswick Township (NJ)

On-site

USD 70,000 - 95,000

Full time

44 hours ago
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Benefits offered by this job

401(k) savings plan
Vacation days (10–12 in first years)
Overtime pay
Health, dental, vision insurance

Job summary

US Pharma Lab in New Jersey is seeking a Senior QA Coordinator to support the Quality Assurance group by ensuring SOPs, batch records, and GMP documentation align with 21 CFR rules. You will coordinate QA programs, collect on-floor samples, and assist with audit readiness to sustain continuous production.

The role requires 3–5 years in nutraceutical/pharmaceutical QA, strong documentation skills, and proficiency with MS Office and eQMS.

Qualifications

  • Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related field.
  • Minimum 3–5 years of QA experience in a nutraceutical, dietary supplement, or pharmaceutical manufacturing environment.
  • Strong knowledge of GMP, 21 CFR Part 111,117 and other relevant quality standards.
  • Detail-oriented with strong organizational and documentation skills.
  • Proficient in Microsoft Office; experience with electronic Quality Management Systems (eQMS) preferred.
  • Excellent communication and problem-solving skills.

Responsibilities

  • Oversee and maintain GMP documentation systems, including SOPs, batch records, deviations, CAPAs, change controls, and training records.
  • Issuance of Manufacturing / Coating / Packaging Batch Cards
  • Collects samples from on floor production for further testing and retention
  • Distributes testing samples to Inhouse testing Analytical , Elemental and Microbiology Lab
  • Preparation of different types of In process Labels for production , QA samples to be provided along with the Batch Records
  • Scanning , photocopy, filing of GMP documents per Batch Product requirements
  • Coordinate Finished Product release in Syspro
  • Performs Sampling of materials / products per procedures as needed
  • Reads and understands approved specifications/standards assigned to the project
  • Keeps up to date with the regulatory requirements around documentation and implements changes if necessary.
  • Work with internal teams to obtain an in-depth understanding of the processes and documentation requirements.
  • Collaborate with Manufacturing, R&D, QC, and Regulatory teams to ensure seamless execution of quality processes.
  • Play an active role on quality management team within the organization
  • Any other duties which may be assigned from time to time

Skills

QA documentation
GMP compliance
Regulatory knowledge
SOP writing
Change control
Risk assessment
Data integrity
Problem solving

Education

Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field

Tools

Microsoft Office
eQMS

Job description

US Pharma Lab in New Jersey is seeking a Senior QA Coordinator to support the Quality Assurance group by ensuring SOPs, batch records, and GMP documentation align with 21 CFR rules. You will coordinate QA programs, collect on-floor samples, and assist with audit readiness to sustain continuous production.

The role requires 3–5 years in nutraceutical/pharmaceutical QA, strong documentation skills, and proficiency with MS Office and eQMS.

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