Quality Assurance

  • location: Sunnyvale, CA
  • type: Contract
  • salary: $28.05 - $33 per hour

job description

Quality Assurance

QA Specialist

Job Summary

Assists in maintaining compliant, efficient internal quality systems and procedures related to the manufacture, packaging, testing, and disposition of drug substances and drug products at CMOs. Quality systems include, but are not limited to: Annual Product Review, Product Complaints, Vendor Management, Quality Metrics, Management Review, Change Control, Investigations/CAPAs, and Validations

Job Responsibilities

  • Assists in reviewing master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance will all applicable requirements
  • Reviews executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition
  • Participates in Quality Investigations
  • Assists in reviewing change control requests to ensue compliance with company procedures, cGMP, and other applicable regulations
  • Supports the internal CMC team
  • Participates in internal audits
  • Assists in preparation of quality metrics
  • Assists in updating SOPs
  • Participates in regulatory inspections
Education & Qualifications

  • Minimum BA/BS degree, preferably in a scientific discipline
  • 0-2 years of pharmaceutical experience in a GMP environment
  • Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable
  • Willing to learn new areas of responsibility
  • Detail oriented with sold problem solving acumen
  • Ability to work effectively in a team environment
  • Ability to analyze and reconcile moderately complex issues
  • Must have demonstrated initiative and accountability in a fast paced environment
  • Excellent verbal and written communication and interpersonal skills
  • Proficient with computes and word processing software (i.e. Microsoft Office products)
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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