Specialist, Quality Assurance - Batch Release

This is currently a hybrid role that requires at least 3 days per week in the Schaumburg, IL corporate office.

Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.

We are seeking a Quality Specialist that will be responsible for the execution of batch record reviews and associated product quality issue resolution. Authorizes shipments from contract manufacturing organizations (CMO) once all applicable documentation has been reviewed and deemed acceptable. Provide direct support and guidance to new product launch initiatives and supply chain concerns. Ensure standards and requirements are met for all executed activities. Support 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.

This person will be expected to:

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

Candidate Qualifications:

• Bachelor’s degree in Scientific related field
• 2 years of previous experience in a Quality related position and knowledge of GMP, GLP and FDA trends
• 2 years of hands-on experience with Chemistry instrumentation including HPLC
• TrackWise software experience preferred
• Must have excellent organizational and project management skills to coordinate multiple projects
• Strong interpersonal communication skills required – verbal, written and presentation

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.