Specialist, Quality Assurance - Batch Release

Sagent Pharmaceuticals • Hoffman Estates, IL

9d • $70,000 - $85,000 • Hybrid

About The Position

Sagent Pharmaceuticals is seeking a Quality Specialist that will be responsible for the execution of batch record reviews and associated product quality issue resolution. This role authorizes shipments from contract manufacturing organizations (CMO) once all applicable documentation has been reviewed and deemed acceptable. The specialist will provide direct support and guidance to new product launch initiatives and supply chain concerns, ensuring that standards and requirements are met for all executed activities. This position will also support the existing quality systems, including executing SOPs and data management activities in association with the company’s management review process. The specialist can interface with the company’s partners to clarify, assess, and/or approve product quality concerns.

Requirements

• 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
• Must have excellent organizational and project management skills to coordinate multiple projects
• Strong interpersonal communication skills required – verbal, written and presentation

Nice To Haves

• TrackWise software experience preferred

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level