MQA Specialist - 2nd Shift

Role Summary

MQA Specialist - 2nd Shift is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The role involves in-process batch record review, resolving batch-related issues, ensuring proper good documentation practices, and performing routine environmental monitoring in 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 communication and interpersonal skills; ability to clearly convey complex issues to management.
• Auditing and QA oversight capabilities; ability to identify and address deviations.

Additional Requirements

• None specified