Sr Quality Assurance Specialist

About the role

Provide Quality oversight to QC Metrology, Technology Transfer, and the laboratories (Chemistry and Microbiology) by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations. Also provides support of the Empower network, laboratory network and standalone computer systems that support the laboratories. Coordinates installation and maintenance of standalone and networked computer hardware and software within the laboratories. Troubleshoots hardware and software problems and provides general user support as required.

Responsibilities

• Support the plant by overseeing the following systems, but not limited to: Technology Transfer: process validation, cleaning validation, continuous process verification, process improvements, packaging development, thermal cycling; Chemistry: method validation, equipment qualification, metrology, stability program, raw material, component release, USP updates; Microbiology: filter validation, method validation
• Work in partnership with all plant groups towards the goal of producing quality products by: Reviewing/approving protocols, investigative studies, raw data and reports
• Review/approve changes in production batch records and implementation of new batch records
• Review/approve deviations, OOSs (out of specification), OOTs (out of trend), OOTs (out of tolerance) and change controls
• Perform audit trail review of all analytical equipment used in the laboratories
• Support computer systems that support the laboratories
• Maintain administrator support for the Empower network specific to the site, exclusive of IT’s responsibilities for system backup and support
• Provide high level technical support for all users
• Review operational systems for quality and compliance to standards and software upgrades
• Audit network for compliance to cGMP regulations
• Create and maintain documentation for all procedures and systems that support the laboratories
• Perform other duties as assigned by Management

Benefits

• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits: medical, prescription drug, dental and vision coverage
• Life insurance
• Disability