What are the responsibilities and job description for the Manufacturing Quality Specialist - 3rd Shift position at Fagron Sterile Services?
About the job
The MQA Specialist reports to the Quality Assurance Manager and works closely with Operations personnel and Environmental Monitoring in managing all unplanned incidents, media fills, production audits, and addressing any quality related questions. Specialist will assist with all post-production related events and coordinate resolution with Pharmacists and Leads.
Supervise and / or mentor Manufacturing Quality Assistants. Set expectations and provide guidance for professional growth within the MQ department.
Ability to identify and report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.
Provides review of production specific Deviations / Investigations, CAPAs, Change Controls
Assist 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
Prepares weekly / monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
Responsible to maintain all testing equipment in compliance, calibration and certification.
Assists in developing policies and procedures related to QA Promptly communicates with Operations regarding complaints, product issues / variances.
Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation Enforce 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 Assist 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.
Set yourself apart
Profile / Experiences
High School Diploma with a BS / BA degree preferred.
Minimum 5 years of pharmaceutical experience, Quality and compliance background is preferred.
Ability to multi-task, effectively communicate and make decisions
Oversight of operations with a focus on Sterility Assurance Knowledge of QMS and CAPA related tools or systems is preferred.
Environmental, monitoring or audit experience is an asset.
Experience with inspections and inspection readiness activities preferred.
What's on offer?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
