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QA Inspector I (2nd Shift- 1p-9:30p (Monday - Friday)

United States - California - Foster CityQualityRegular

Job Description

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses

worldwide. As a QA Inspector you are responsible for:

Role Summary:

This is an entry-level position engaged in inspecting in-process / finished product, incoming, intermediate, and outgoing materials for proper identification and conformance to approved specifications. Conducts routine tasks in accordance with SOPs and detailed instructions. Assignments range from routine to basic where analysis of situation or data requires a review of simple and fairly identifiable factors.

Key Responsibilities:

  • Following detailed instructions under supervision, assists with QA inspection of, incoming materials, clinical/commercial, in-process and finished product.
  • Performs routine inspections of incoming, intermediate, and outgoing materials for proper identification and conformance to approved specifications.
  • Assists with the sampling and identification (quarantine, approved, on hold, or rejected) of all materials in accordance with current Good Manufacturing Practices (GMPs) requirements.
  • Documents, files and maintains inspection records.
  • Performs basic tasks in support of the collection, retention and storage of finished product and packaging component retain samples.
  • Performs basic tasks in support of the distribution, retrieval, and filing of controlled documents (SOPs, Specifications, and Test Methods) as well as other Quality Assurance documents.
  • Working knowledge in Computerized Management systems (CMS).
  • Ability to follow direction and work with only moderate supervision.
  • Prior experience in a cGMP related industry is desirable.
  • Performs basic Enterprise Resource Planning (ERP) / Manufacturing Electronic System (MES) execution.
  • Receives well-defined instructions on routine work, and detailed instructions on new assignments.
  • Reports deviation from standard procedures to department QA management.

Shift:

  • 2nd shift 1p-9:30p (Mon-Friday)

Basic Qualifications:

  • Prior experience in a cGMP related industry
  • Demonstrates familiarity with written Standard Operating Procedures (SOPs) and Master Batch Records
  • Demonstrates sufficient verbal, written, and interpersonal communication skills to communicate basic information to peers and team lead. Demonstrates working knowledge of Microsoft Office applications and administrative policies.
  • Demonstrates ability to follow directions and work with only moderate supervision.
  • Able to pass annual vision test, eye exam for Inspection.
  • High School Diploma with at least 2 years of relevant experience