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Specialist, Quality Assurance - Change Control

Application Deadline: July 31, 2019

Location: SCHAUMBURG, IL, USA

Job Summary / Overview:

Responsible for the support and approval of change controls for all labeling and external changes involving our Contract Manufacturing Organizations (CMO). Work in partnership with Regulatory Affairs, Global Alliance Management, Labeling and CMOs to ensure Sagent’s requirements for changes are met in accordance with FDA requirements. Support the existing Quality Management System (QMS) including executing SOPs and data management.

Success in the role is measured on:

  • On time releases and launches as it relates to change controls

  • No regulatory action against Sagent as relates to labeling or external change controls

  • Accurate data management supporting Sagent’s QMS


Key Duties & Responsibilities:


  • 100% - Review and provide QA approval for external and label changes performed by Sagent’s CMOs. Review associated documentation for external changes such as finished product specifications, batch records, packaging specification sheets and testing specifications. Responsible for QA functions of the labeling and external change control processes within the TrackWise system. Review and provide QA approval for labeling/packaging components. Ensures cGMP compliance and accuracy in comparison to the RLD. Provide guidance and support in all aspects of cGMP to our CMOs including in particular good documentation practices. Act on Manager Quality Assurance behalf, as designated.


Knowledge or Experience:

  • Excellent knowledge of current GMP,GLP and Aseptic practices

  • Strong familiarity with TrackWise software

  • Must possess exceptional communication and interpersonal skills

  • Expertise in microbiology, or chemistry, aseptic processing, and terminal sterilization processes

  • Possesses strong organizational skills for prioritizing workload and responsibilities

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

  • Ability to manage indirect relationships successfully

  • Proficient with PC – based word processors, databases and spreadsheets

  • Attention to detail

  • Elevates issues to upper management


Minimum Qualifications / Experience:

  • Requires at least 5 years of progressive challenging QA/QC experience in the pharmaceutical or related industry.

  • In depth knowledge of current GMP, GLP and Aseptic Practices

  • Must have excellent organizational skills

  • Strong interpersonal communication skills required

  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective

  • Travel not required


Education / Certifications:

  • BS degree preferred with at least 5 years of QA/QC experience in the pharmaceutical or related industry.


 

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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