Manufacturing QA Specialist

Job Description

Business: Pharma Solutions
Department: Quality Assurance
Location: Lexington

Job Overview

The Manufacturing QA Specialist helps to ensures compliance with regulations and standard operating procedures by performing quality oversight activities during the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products.

Reporting Structure

Reports to QA Supervisor

Key Responsibilities

• Review executed batch records and executed protocols and work with departments to address and correct issues.
• Review pest control, calibration, HEPA certification, logbooks, and work order documentation
• Execute "on the floor" activities (line clearances, product inspection, interim problem solving, etc.)
• Provide QA oversight and perform walkthroughs of manufacturing areas
• Troubleshooting systemic GMP issues.
• Provides leadership on projects and within systems that interface with other departments
• Provides SME support, review and approval during meetings, audits, investigations, technical reports, etc.
• Execute assigned training and development plan

Education Requirements

• High school education or equivalent
• Bachelor's Degree in the physical or biological sciences or related scientific field preferred

Experience

• Previous experience performing quality related activities within a manufacturing environment, pharmaceutical manufacturing preferred
• Previous experience working within strict regulatory guidelines, cGMP or FDA preferred

Competencies

• Working knowledge of cGMP and applicable FDA regulations
• Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
• Demonstrated ability to effectively communicate both verbally and in writing
• Ability to read and follow written instructions
• Detail oriented
• Understanding of sterile manufacturing preferred
• Technical writing skills preferred