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Quality Auditor

Application Deadline: December 31, 2018

Location: Schaumburg, ILLINOIS, USA

Job Summary / Overview:

Coordinate Sagent’s Supplier Audit program to ensure that external vendors comply with current Good Manufacturing Practices (cGMPs) and other regulations. Lead Sagent’s Internal Audit program to ensure that internal functions comply with regulations. Support compliance by performing audits, gathering metrics, and benchmarking cGMP requirements.

Key Duties & Responsibilities:

  • Supplier Audit:

  • Monitor audits from outside vendor: schedule audits, pre-audit call, review audit reports, download audit records from vendor database.

  • Report audit findings to suppliers, monitor supplier responses, and review corrective action objective evidence.

  • Enter audit findings and supplier responses into TrackWise.

  • Perform selected domestic supplier audits.

  • Internal Audit: Perform Sagent Internal Audits (5-6 per year).

  • Quality Agreements: Route Quality Agreements for approval.

  • Management Review – Support the Management Review process by compiling and trending quality data.

  • Inspection Management – Serves as a subject matter expert for Supplier and Internal Audits during the company’s inspections by regulatory agencies.


Knowledge or Experience:

  • In-depth knowledge of current GMP and GLP, as well as global compliance trends and guidelines.

  • Understanding of quality auditing process and pharmaceutical quality systems.

  • Proficient with PC-based word processors and spreadsheets.

  • Proficient with electronic quality management systems for supplier audit.

  • Strong organizational skills for prioritizing workload and responsibilities.

  • Strong written and verbal communication, interpersonal, negotiations and problem solving skills required.


Minimum Qualifications / Experience:

  • Minimum of 5 years of experience in the pharmaceutical industry.

  • Background in drug product filling or finishing, preferably with sterile injectables.

  • Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines.

  • Must have excellent organizational and project management skills.

  • Effectively prioritize workload and manage time to complete assigned projects within established timelines and goals.

  • Ability to oversee multiple and competing projects in a fast-paced, changing team environment.

  • Strong interpersonal communication skills required – verbal and written.

  • Up to 20% travel may be required.


Education / Certifications:

  • Bachelor’s degree in engineering, chemistry, biology, microbiology or mechanical engineering is required

  • Certified Quality Auditor certification is preferred


 

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

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