Strategic Operation Associate II
On-sitePortsmouth, New Hampshire, United States
Job Summary
Lead and support projects focused on process improvements, operational readiness, and manufacturing efficiency. Manage project timelines, deliverables, KPIs, and change control activities while analyzing manufacturing processes to identify improvement opportunities. Support investigations related to manufacturing events, quality issues, and operational challenges by collaborating with Manufacturing, Quality, Engineering, Validation, and MSAT teams. Participate in risk assessments, drive CAPA actions to completion, and support technical transfers for new campaigns. Review manufacturing documentation including SOPs, work instructions, and batch records, while supporting equipment implementation and team training on new procedures. This role follows a Monday through Friday standard business hours schedule.
Required Qualifications
- High school diploma or equivalent
- 3-5 years of experience in biotechnology, pharmaceutical manufacturing, quality, engineering, or a related industry
- Experience working in a GMP-regulated manufacturing environment
- Knowledge of manufacturing processes, change controls, investigations, CAPAs, and quality systems
- Strong technical writing, organizational, and problem-solving skills
- Strong communication and stakeholder management abilities
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Monday through Friday standard business hours schedule
Desired Qualifications
- Bachelor's degree in a scientific, engineering, manufacturing, or related field
- Experience leading or supporting projects and continuous improvement initiatives
- Familiarity with SAP or similar business systems
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