Manufacturing Support Specialist

As a member of AIRMs MTS team, the Manufacturing Support Specialist shall play a critical role in supporting other Good Manufacturing Practice (GMP) teams with technology transfer, quality management system (QMS) and continuous improvement activities. The major job functions include, but are not limited to, developing procedures and driving change controls, deviations, and CAPAs to completion, as well as implementing continuous improvements to the existing facility, programs and practices with the aim of commercial readiness. Essential Job Responsibilities: Provide input on/carry out investigations on medium and high-level deviations. Support change control activities related to manufacturing – process changes, new product introduction, new equipment and technology introduction, etc. Support site and corporate objectives to deliver programs as per established timelines. Coordinate and assist with technology transfer activities. Support equipment qualification/validation activities in the capacity requested by Manufacturing. Assist with Data Integrity (DI) assessments of manufacturing equipment. Develop and implement Corrective and Preventive Actions (CAPAs). Implement continuous improvement projects. Perform risk assessment activities including raw material risk assessments. Develop and draft and revising documentation including study protocols/reports, batch records and standard operating procedures (SOPs). Support commercial readiness activities. Organizational Context: Reports directly to the Department Head, BioPharma Manufacturing Technical Support (MTS) Qualifications: Required: Bachelor’s degree in Quality, Manufacturing, Biology, Engineering, Life Sciences or a discipline justifiably related to pharmaceuticals/biopharmaceuticals. Strong oral, written and interpersonal skills. Willingness to collaborate cross-functionally and with external vendors, original equipment manufacturers, etc. Preferred: More than 1 year of experience in a Quality or Manufacturing environment (pharmaceutical or medical device preferred). Knowledge of QMS documentation, risk management and risk documentation. Basic understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Proficiency using Microsoft Word, Excel, and PowerPoint. Detail-oriented with good organizational skills. Basic project management skills are a bonus. Ability to manage changing priorities and maintain timelines for multiple projects in a fast‑paced setting. Ability to work effectively independently and as part of a team. Experience with continuous improvement projects is highly desirable #J-18808-Ljbffr