MQA Specialist - 2nd Shift

Role Summary

The Manufacturing Quality Assurance (MQA) Specialist – 2nd Shift is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The MQA Specialist will work closely with production personnel to complete in-process batch record review, resolve batch related issues, and ensure proper good documentation practices. In addition, the MQA Specialist will be responsible for performing routine environmental monitoring to assess the viable and nonviable particulate levels within classified manufacturing rooms and support rooms.

Responsibilities

• Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes. Ability to make independent decisions regarding quality related concerns or issues.
• Address daily quality concerns and questions related to operating and environmental issues.
• Clearly communicate complex issues to Management personnel.
• Work closely with production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
• Complete gown qualification and maintains status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Perform aseptic gown training and certification sampling.
• Identify deviations and ensure the deviations are initiated by the appropriate personnel.
• Perform AQL checks on product when necessary and maintain AQL qualification status.
• Perform and document assessments of aseptic behavior inside the aseptic manufacturing area. Must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
• Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas.
• Collect facility waters and submit for testing.
• Requisition of materials, maintaining inventory, and receive and store prepared media.
• Enumerate bacteria and report excursions, if required.
• Perform additional duties and responsibilities as assigned.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
• Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
• Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP‚Äôs, FDA, OSHA and other regulatory agencies.

Qualifications

• Bachelor‚Äôs degree in science, engineering field from an accredited university required
• Minimum one (1) year experience in the pharmaceutical industry (cGMP environment) and aseptic technique.
• Ability to get gown certified within 30 days.
• Physical requirements include standing and walking up to 8 hours (4 hours at a time for aseptic processing area), lifting or moving up to 35 pounds and reaching with hands and arms up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl up to 1 hour.
• Good communication (oral, written) and interpersonal skills are necessary.
• An acceptable visual acuity test is required for this position.

Skills

• Proficient knowledge of manufacturing processes and standard operating procedures.
• Strong ability to communicate complex issues to management.
• Experience with aseptic technique and environmental monitoring.

Education

• Bachelor‚Äôs degree in science or engineering field from an accredited university

Additional Requirements

• None beyond the qualifications listed