Manufacturing Quality Assurance Specialist - 3rd Shift

About the job

The MQA Specialist reports to the Manufacturing Quality Manager and works closely with Operations personnel and Environmental Monitoring Technicians to complete on-the-floor audits and training of behavior and technique.

Key Responsibilities

• Identify and report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Timely and accurate process review of batch records and QA checks within the manufacturing process
• Provides review of production specific Deviations / Investigations, CAPAs, Change Controls
• Aid in generating procedures related to Manufacturing QA functions / activities
• Observe and identify conformance to defined procedures and batch specific steps within the aseptic areas
• Periodically review records to verify that quality standards for each drug product is met
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Prepare weekly/monthly reports, prepare metrics and trends data to identify and prioritize continuous improvement opportunities
• Maintain compliance with QA processes, Equipment Qualification, and Computer System Validation principles
• Support all regulatory and customer quality audits
• Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantly
• Aid CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed
• Conduct and report the findings of internal investigations of compliance issues

Qualifications

• BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
• Minimum 2 years directly related experience supporting compliance in a quality/compliance function /applicable compliance field
• Oversight of operations with a focus on Sterility Assurance
• Ability to multi-task and prioritize
• Experience supporting compliance in a quality/compliance/ function /applicable compliance field preferred
• Knowledge of QMS and CAPA related tools or systems is preferred
• Environmental, monitoring or audit experience is an asset