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Quality Specialist - Batch Release

Application Deadline: October 31, 2019

Location: SCHAUMBURG, IL, USA

Job Summary / Overview:

Responsible for the execution of batch record reviews and associated product quality issue resolution. Authorizes shipments from Sagent’s contract manufacturing organizations (CMO) once all applicable documentation has been reviewed and deemed acceptable. Will provide direct support and guidance to new product launch initiatives and supply chain concerns. Ensure standards and requirements are met for all executed activities. Supports the existing quality systems, including executing SOPs and data management activities in association with the company’s management review process. Can interface with the company’s partners to clarify, assess, and/or approve product quality concerns.

Key Duties & Responsibilities:

  • Review and approve batch records related to cGMP documentation- deviation and investigation reports, QC data, CoA, CoC, product labeling and specification sheets, and all documentation supporting shipment of products prior to shipment, including temperature profiling data. Provide guidance and support in all aspects of cGMP to our CMOs including in particular good documentation practices and root cause analysis during investigations.

  • Ensure all applicable data is accurate, up to date, and defendable to regulatory authority.

  • Provide ongoing support to the existing Quality Management System and training programs.

  • Write, review, or implement new standard operating procedures and policies, as necessary.

  • Generate and manage validation protocols and final reports supporting packaging and shipping validation studies and temperature profile assessments.

  • Participate on Global Alliance Management project teams to communicate quality concerns and team progress.


Knowledge or Experience:

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

  • Must possess exceptional communication and interpersonal skills.

  • Must have excellent organizational and project management skills to coordinate multiple projects.

  • Expertise in microbiology, 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 and projects successfully.

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

  • Attention to detail.

  • Elevates issues to management, when appropriate.


Minimum Qualifications / Experience:

  • Requires at least 3 years of progressive, challenging QA/QC experience in the pharmaceutical or related industry.

  • In depth knowledge of current GMP and GLP as well as FDA trends and guidelines

  • Must have excellent organizational and project management skills to coordinate multiple projects

  • Strong interpersonal communication skills required – verbal, written and presentation.

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

  • Broad career progression within the pharmaceutical drug development and/or drug manufacturing industries strongly preferred; with specific experience in quality, regulatory, and manufacturing preferred.

  • Travel not typically required, or can be less than 5% per annum.


Education / Certifications:

  • BS degree preferred, with at least 3 years of progressively challenging 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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