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Quality Assurance Specialist - Change Control

Application Deadline: May 31, 2020


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 Sagent owned manufacturing sites in US and Canada. 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:

  • Review and provide QA approval for external changes performed by Sagent’s CMOs.

  • Review associated documentation for external changes such as finished product specifications, batch records, packaging specification sheets, testing specifications and deviations.

  • Responsible for review and approval for QA functions of labeling, external, IT and Controlled Document 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

  • Familiarity with TrackWise and Veeva Vault software a plus

  • 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

  • Minimum travel, less than 5%.

Education / Certifications:

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

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