Quality Assurance Associate

Company: Veloxis Pharmaceuticals, Inc.
Location: Cary
Posted on: February 19, 2021

Job Description:

This position contributes to the Company's success by managing the cGMP quality systems required to monitor the quality of third-party Contract Manufacturing Organizations (CMOs) throughout the entire product lifecycle.Summary of Key Responsibilities:--- Responsible for ensuring the conformance of the CMOs manufacturing, packaging, and/or testing processes to cGMP, Company policies and procedures, Quality agreements, as well as the Company's specific requirements.--- Primarily responsible for batch record review and disposition of the Company's products.--- Communicates cross-functionally and collaborates to manage comment resolution on batch records and deviations in a timely manner.--- Interacts with peers (internally and at CMOs) with the purpose of coordination of disposition activities, investigations, discussions pertaining to strategic initiatives and compliance-related issues.--- Reviews and approves internal deviations and root cause analysis, including CAPA effectiveness.--- Reviews and approves investigations, OOSs, CAPAs associated with batch disposition ensuring a thorough review to process, methods, validation, as well as all applicable regulatory rules and regulations.--- Supports the resolution of both technical and compliance issues/gaps with moderate technical problem solving within function and in partnership with Technical Operations.--- Reviews and approves packaging components, labeling, specifications, and all related quality activities related to finished product packaging.--- Can lead small groups to investigate, recommend improvements to management, and monitor effectiveness.--- Investigates internally and with CMOs and licensing partners on the investigation of product complaints.--- Contributes to the preparation and/or review of annual product review and updates for regulatory filings, batch release metrics, and department reporting, as applicable.--- Manages batch record related changes.--- Reviews and approves change controls as necessary.--- Performs internal audits as required by the Company's audit program.--- Participates in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities, and special projects.--- Utilizes Company's eDMS (Vault QualityDocs) for revising and approving its SOPs, along with batch disposition and other quality components as necessary. --- Ensures archival of all Quality documents in compliance with the Company's records retention policy. --- Creates, reviews, and revises SOPs.--- Manages KPIs for batch disposition and associated batch disposition activities; contributing to monthly management report as it relates to assigned functions.--- Supports regulatory authority and licensing partner inspections as needed.--- Performs additional assignments as directed by manager.Required Qualifications and Skills:--- Bachelor's Degree, preferably in scientific/technical discipline with 2-5 years' relevant industry experience. --- General understanding of the manufacturing process. --- Excellent communication and negotiation skills; capable of making decisions, problem solving, collaborate with other team members in a positive manner, and working in a leadership role.--- Excellent organizational skills and ability to work on multiple projects with competitive timelines is required.--- Strong attention to detail.--- General understanding of FDA regulations--- Demonstrated ability to work effectively in cross functional team environment.--- Strong proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, etc.), Adobe Pro and clinical trial software/programs

Keywords: Veloxis Pharmaceuticals, Inc., Cary , Quality Assurance Associate, Other , Cary, North Carolina