Quality Systems Engineer

The Senior Quality Systems Engineer will support quality management systems within a pharmaceutical manufacturing environment, with emphasis on GMP compliance, Change Control, quality documentation, validation, and continuous improvement. This position will oversee quality system activities, review and approve controlled documentation, support audits and inspections, and collaborate across manufacturing and technical functions., o Support and maintain Quality Management Systems and site Quality and Compliance programs. o Lead Change Control activities from initiation through implementation, review, and approval. o Provide records management and Change Control expertise supporting compliant site activities. o Review and approve SOPs, protocols, risk assessments, and other quality records. o Maintain quality systems in compliance with current Good Manufacturing Practices and applicable regulatory requirements. o Support process and cleaning validation, computer system validation, and equipment, facility, and utility qualification activities. o Support Annual Product Review, quality metrics, data trending, and continuous improvement initiatives. o Participate in internal, partner, and regulatory inspections and audits as required. o Support site quality projects, corporate standard assessments, and cross-functional quality initiatives. o Collaborate with Operations, Manufacturing Science and Technology, Research and Development, Supply Chain, and Quality Control teams. o Analyze complex quality issues and apply independent judgment and problem-solving to determine appropriate actions., o Quality Systems o GMP Compliance o Change Control o Quality Assurance o Pharmaceutical Manufacturing o Technical Writing o SOP Review o Risk Assessments o Quality Documentation o TrackWise o Veeva o Validation

o Bachelor’s degree, preferably in a scientific discipline such as Biology, Chemistry, or a closely related field, or equivalent education and experience. o Minimum five years of relevant Quality Systems and GMP/Compliance experience within a pharmaceutical manufacturing environment. o Strong experience with Change Control and quality documentation management. o Experience reviewing and approving SOPs, protocols, risk assessments, and quality records. o Quality Assurance experience within pharmaceutical production. o Strong knowledge of current Good Manufacturing Practices and pharmaceutical quality systems. o Strong technical writing, documentation, and cross-functional communication skills. o Ability to work independently, exercise sound judgment, and make higher-level quality decisions. o Proficiency with MS Office and electronic quality/document management systems. Preferred Qualifications: o Seven or more years of progressive pharmaceutical industry experience. o Direct experience with pharmaceutical manufacturing and various dosage forms. o Experience supporting Health Authority inspections. o Experience with TrackWise, Veeva, Learning Management Systems, Electronic Document Management Systems, and Enterprise Resource Planning systems. o Project management and advanced presentation skills. o Experience with quality metrics, data trending, and continuous improvement.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable. Pay Range: $45/hr - $50/hr