GMP Operations Specialist: CAPA & Deviation Expert

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Hybrid; USD 52,000 - 76,000; Full time

Benefits offered by this job

Benefits from day 1

Volunteer time off

PTO

Wellness time off

Paid holidays

401(k) plan

Job summary

Grand River Aseptic Manufacturing Inc. is seeking an OTS Specialist to execute routine technical support across GMP manufacturing operations on-site at GRAM facilities.

You will collaborate with Quality, Operations, and Engineering to complete deviation investigations, CAPA activities, and site data analysis. Candidates should have a life sciences or engineering background with 0–3 years in pharma manufacturing and strong skills in MS Word/Excel/Outlook.

Qualifications

• Bachelor’s degree in life sciences, engineering, or equivalent training/experience.
• 0–3 years of experience in pharmaceutical manufacturing.
• Proficient in MS Word, Excel and Outlook.

Responsibilities

• Work with Operations, Engineering, Maintenance, Project Management and Quality to gather documentation for deviation investigations.
• Apply risk analysis, root cause and corrective action tools for deviations.
• Author and revise site procedures to address CAPA and continuous improvement.
• Provide corrective actions for GMP discrepancies and intra-batch process monitoring and reporting.
• Support validation with implementation and commissioning of clean room spaces and process equipment.
• Initiate revisions to cGMP procedures and master batch records as applicable.
• Review and trend site quality metrics and assist with site change controls.

Skills

GMP knowledge

Deviation investigation

Cross-functional collaboration

Education

Bachelor’s degree in life sciences, engineering, or equivalent training/experience

Tools

MS Word, Excel, Outlook

Job description

Grand River Aseptic Manufacturing Inc. is seeking an OTS Specialist to execute routine technical support across GMP manufacturing operations on-site at GRAM facilities.

You will collaborate with Quality, Operations, and Engineering to complete deviation investigations, CAPA activities, and site data analysis. Candidates should have a life sciences or engineering background with 0–3 years in pharma manufacturing and strong skills in MS Word/Excel/Outlook.