How will you make an impact?
Responsible for leading department quality investigations to determine root cause and both corrective & preventative actions for top quality losses. Proactively leads quality improvements for the department
What will you do?
- Responsible for conducting investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met.
- Lead the quality response process including initial response, containment, root cause investigation and determining appropriate corrective & preventive actions
- Writes investigation reports in Trackwise (Quality System).
- Responsible for leading huddle process to achieve timely deviation and action closure to meet departmental goals
- Proactively drives quality improvements to achieve department right first time (RFT) and quality compliance goals.
- Participates in inspection readiness activities and may also be involved in audits and inspections by regulatory agencies.
- Models effective and constructive communication and interactions with technical departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
- Requires a passion for problem solving, attention to detail, good organizational skills, a sound understanding of cGMPs and Manufacturing/ Packaging.
- Requires interaction with the operations personnel, QA GMP Services, Process Engineers, Records/Release, Quality Control, QA Regulatory, Engineering, and Clients.
- Position requires flexibility at times to complete interviews/investigations with night and end of week shifts. Escalates critical events and investigation findings to Production and Quality Assurance Management.
- May represent the production department on various project teams such as validation, engineering phase review meetings, and daily department communication meetings.
- May also assist in developing and maintaining various quality and training systems and programs.
How will you get here?
- Bachelor’s Degree in Engineering or Related Field is required.
- Quality, process and manufacturing investigation and technical writing experience is desired
- Equivalent combinations of education, training, and relevant work experience may be considered
Knowledge, Skills, Abilities
- Background in cGMP’s requirements
- Lean Six Sigma problem solving skills
- Experience writing technical reports
- Must be able to manage and prioritize daily tasks with minimal supervision
- Microsoft Office Word, Excel and PowerPoint
- Must be able to learn and navigate through investigation, quality and ERP systems
- Have flexibility to work various shifts times if needed to complete work content.
- Ability to influence change and manage multiple projects