Quality Specialist - Elkton, United States - Spectraforce Technologies

Description

• Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role.
• Previous experience in food or pharmaceutical environment in regulatory/inspection role.
• Previous experience in project management, process data analysis. Lean Six Sigma Certification Previous Experience with SAP,MEDS, etc. Additional: Beta Lactam screening required for this role.
• The successful candidate will support aseptic operations.

• The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
• The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.
• The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning. May perform quarantine functions and accountability reviews. Supports special projects as assigned.
• The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
• May work with customers to resolve problems and to satisfy quality and production needs.
• Follows site safety requirements. Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
• Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams. The individual tracks/reports metrics as needed. May provide training/ presentations as needed. May help with regulatory inspections.