Senior Quality Assurance Specialist II

1 week ago


Piscataway, New Jersey, United States Amneal Pharmaceuticals Full time

About the Role:

We are seeking a highly motivated and experienced Quality Assurance Specialist II to join our team at Amneal Pharmaceuticals.

Job Summary:

The Quality Assurance Specialist II will be responsible for ensuring compliance with established specifications, regulations, and company policies. This role will involve monitoring and controlling all phases of drug manufacturing, including the receipt, inspection, and testing of raw materials and packaging components.

Main Responsibilities:

  • Conduct inspections and tests on incoming raw materials and packaging components to ensure conformance to specifications;
  • Maintain detailed records of sampling, inspections, and testing activities;
  • Assign and verify expiry dates and retest dates for GMP raw materials through vendor COA and in-house COA;
  • Collect packaged product samples for annual room checks (where applicable);
  • Conduct in-process testing per manufacturing and packaging batch record instructions;
  • Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains;
  • Maintain standard weights required to perform daily verification of ng component receipt;
  • Perform labeling components/outserts inspection reports; quarantine and release labels;
  • Issue labeling components/outserts according to packaging order and monitor regular auditing of label room;
  • Fill out QA final labeled product inspection report and final line clearance which includes labeling and packaging reconciliation;
  • Monitor facility and product environmental operating conditions;
  • Review engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions);
  • Review online batch records in terms of completeness of signatures, entries, and actual reconciliations/yields prior to initiation of next processing step;
  • Verify functionality of all equipment and associated controls during the batch run;
  • Maintenance of retention sample room and monitoring of temperature and humidity, replacement of chart records as per schedule, review of log and disposition of samples;
  • Disposition of rejected material and returned drug products as per SOP;
  • Perform environmental monitoring in accordance with established schedule (where applicable);
  • Perform applicable testing and prepare report for customer complaints;

Requirements:

  • Bachelor's degree or equivalent experience;
  • 2+ years' experience in QA or related field;
  • High energy level and organizational skills;
  • Advanced computer skills (Word and Excel);
  • Good basic math knowledge and excellent attention to details;

What We Offer:

  • Competitive salary: $85,000 - $105,000 per year;
  • A comprehensive benefits package including medical, dental, and vision insurance;
  • Generous 401(k) matching program;
  • Opportunities for career growth and professional development;
  • A collaborative and dynamic work environment;


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