Senior QA Lead - Pharma Distribution & Compliance

Acrotech Biopharma inc.

East Windsor Township (NJ)

On-site

USD 37,000 - 40,000

Full time

14 days+
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Benefits offered by this job

Medical benefits
Dental plan
Vision plan
Life insurance
Disability insurance
FSA/HSA
401(k) match
Employee Assistance Program
Critical illness insurance
Identity protection
Paid time off

Job summary

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide strategic QA support for warehouse and distribution operations.

You will ensure compliant receipt, inspection, and release of pharmaceuticals under GDP, DSCSA serialization, and FDA import regulations, while leading deviations and CAPA processes. Responsibilities include supervising QA documentation, investigations of deviations, and supporting cross-functional regulatory interactions to maintain compliance and

Qualifications

  • Knowledge of GDP, DSCSA, and FDA import regulations.
  • Strong data collection and analytical skills.
  • Excellent communication of technical information to management.

Responsibilities

  • Lead receipt and inspection of pharmaceutical products for GDP/DSCSA compliance.
  • Verify DSCSA serialization, lot traceability, and chain of custody docs.
  • Identify and manage suspect or illegitimate product reports.

Skills

MS Office
Leadership
Data analysis
Attention to detail
GMP knowledge
Communication
Teamwork

Education

Bachelor of Science

Tools

Oracle

Job description

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide strategic QA support for warehouse and distribution operations.

You will ensure compliant receipt, inspection, and release of pharmaceuticals under GDP, DSCSA serialization, and FDA import regulations, while leading deviations and CAPA processes. Responsibilities include supervising QA documentation, investigations of deviations, and supporting cross-functional regulatory interactions to maintain compliance and

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