Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Essential Functions
• Batch Review
o Preparation, review and approval of CMO documentation for batch production
o Review of batch records, addressing discrepancies and escalating where required to management.
o Preparation of disposition and release certification for reviewed batch records.
• CMO Governance
o Management and oversight of third-party supplier activities relating to the manufacture, packaging and testing of product.
o Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.
o Continuous monitoring of product and performance from CMOs.
• Quality Support and Deputation
o Quality record management; deviations, change controls, CAPAs
o Monitoring cold-chain transportation, for both qualification and routine
o CMO Maintenance
o Input into Technical Quality Agreements
o Post-launch support for quality activities in various countries
o Management of delegated projects
• Stability Program
o Protocol review and approval
o Data review and management
• Audits
o Drive the audit readiness program to ensure audit compliance at all times.
o Perform supplier audits as required (CQA certification preferred)
• Quality/QMS Projects
Minimum Requirements
Education / Experience / Skills:
• Bachelor’s Degree in scientific discipline, preferred 5 years’ experience working within Quality roles with increasing responsibility.
• Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
• Knowledge of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211 and CFR 820; knowledge of GDP and ISO 17025 and 13485
• CQA and/or CSQP certification preferred.