Quality Engineer II

Overview

Quality Engineer II is a quality assurance professional with substantial prior experience of working within a Quality or Manufacturing organization in a highly regulated industry. This individual specializes in evaluation of production processes and performance in manufacturing and participates in projects to engineer quality improvements of existing production processes as well as the development of new processes to improve quality and efficiency.

Other job duties include but are not limited to understanding contamination/cross-contamination, observing aseptic practices, performing daily GEMBAs of manufacturing areas, continuously assessing fit and finish of the facility, and performing compliance inspections within manufacturing areas. This role supports Manufacturing by providing Quality input as needed, and requesting the initiation of deviations as they are identified. All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

Will be working on the floor 80% of the time to observe manufacturing doing the process and making sure they are following SOP's and batch records. The other 20% of the time will be at their desk doing quality document review and working through deviations with supervisors.

• Oversee activities and provide perspective and provide QA‑related input
• Collaborate with cross‑functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality
• Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations in preparation for internal quality audits, client audits, and regulatory inspections
• Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross‑contamination
• Participate in client and regulatory audits as a SME on the Fit and Finish, Changeover, and Change Control procedures and practices
• Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time
• GEMBA all active areas daily as well as other areas within the core as scheduled, and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirements
• Perform QA approval of suite and equipment changeover between client processes
• Perform autoclave logbook review and facilitate corrections
• Perform Fit and Finish inspections per the risk assessment and guiding procedures
• Perform monthly aseptic observations of critical activities performed in Biosafety Cabinets
• Attend and actively participate in MFG huddles
• Lead/attend and actively participate in QA OTF Tier 1 huddles
• Act as Quality Management Representative for the company as needed
• Take actions to develop one’s own knowledge and skills
• Perform all training requirements in a timely manner
• Provide training, coaching, and mentorship to new and/or less experienced team members on quality standards and effective strategies
• Qualify new team members to perform tasks that require QSME training
• Write and review deviations in Trackwise as required
• Author, revise, and review procedures in eDMS as required
• Write and implement CAPA’s as needed
• Conduct/participate in investigation interviews/RAPIDs as required
• Develop buy‑in and cooperation to resolve issues and maintain quality culture and standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential

Quality assurance, Inspection, Gmp, Audit, Quality inspection, Root cause analysis, Capa, batch record review, batch record, smartsheet

• Bachelor's Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry) or another science related field combined with a minimum of 3 years of relevant experience is required
• Cleanroom manufacturing experience is highly preferred, but not required along with a comfort level with full ISO 5 and ISO 7 gowning requirements
• Non‑science degrees will be…