Quality Assurance Specialist II

Job Summary

The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience. Under supervision, the individual will be working on the Product Quality Assurance team to support drug product packaging and labeling operations, and product disposition in compliance with cGMP and regulatory guidelines. This individual will also work on quality events, product complaints, and support other quality activities, as required. The individual will be interacting with cross-functional groups such as Supply Chain, Quality Control, MSAT, and Manufacturing departments.

Responsibilities/Essential Duties

• Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures and applicable US and international regulatory requirements for finished drug product distribution.
• Maintain, track, review, and investigate product complaints.
• Review executed production batch records and associated documentation for finished drug product and customized product.
• Review documentation for product release.
• Review deviations, change controls, and CAPAs under supervision.
• Maintain retain inventory of finished drug product.
• Author new or revise existing procedures and/or forms to support continuous improvement of quality operations.
• Support preparation and maintain quality system metrics.
• Support quality activities for internal manufacturing operations, including area approvals, inspections, and other assignments as needed.
• Assist with inspection preparation for regulatory agency inspection or third-party audits, as needed.
• Perform data verification for regulatory submission documents, as needed.
• Act as a compliance resource to provide guidance and assistance towards operations and resolution of deviations, investigations, CAPAs, and change controls.

Basic Qualifications

• Bachelor's degree & 2-5 years' directly related experience.

Preferred Qualifications

• Ability to work with all levels cross-functionally.
• Ability to independently analyze and reconcile simple issues.
• Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instructions on new assignments.
• Strong interpersonal, verbal, and written communication skills.
• Specific vision abilities required by this job may include passing a vision test in order to perform statistical inspections of drug product.
• Strong attention to detail.
• Experience in aseptic manufacturing processes.
• Knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidelines documents.
• Experience with Veeva QMS.
• Proficient with commonly used word processing, database systems, and other software.