Pharma Inspection Line Lead – QC & cGMP

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); On-site; USD 42,000 - 59,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) vesting

Volunteer time

PTO

Wellness time off

Paid holidays

Job summary

Grand River Aseptic Manufacturing Inc. is seeking an Inspector to oversee inspection tasks and support cGMP compliance in the Finishing area. You will lead inspection operations, train staff, and ensure regulatory standards are met across QA processes.

The role requires knowledge of parenteral product inspection, FDA guidelines, and GMP practices, with proficiency in MS Office and Master Control. OT hours and weekend work may be required.

Qualifications

• 1+ years relevant experience as a qualified inspector of parenteral products.
• Knowledge of QA principles and procedures in pharma/biopharma/manufacturing.
• Experience with cGMP, FDA guidelines and multinational regulatory standards.

Responsibilities

• Provide direction and support to the inspection team to ensure cleanliness, organization, and maintenance of the operational areas and equipment.
• Verify and classify rejects; provide feedback to inspectors as needed.
• Perform equipment setup and operation.
• Perform Good Documentation Practices with accuracy and according to regulatory guidelines.
• Assist in completion of batch record materials.
• Navigate Master Control and its general use.
• Maintain data trending reports from visual inspection data.
• Train all inspection employees with support from Finishing Trainer.
• Document and communicate professionally with Finishing and cross-functional teams.
• Participate in Continuous Quality and Safety Improvements.
• Support Agency, customer and vendor audits as needed.

Skills

QA Principles

cGMP Knowledge

FDA Guidelines

GMP Standards

MS Office

Tools

Master Control

Microsoft Word

Microsoft Excel

Outlook

Job description

Grand River Aseptic Manufacturing Inc. is seeking an Inspector to oversee inspection tasks and support cGMP compliance in the Finishing area. You will lead inspection operations, train staff, and ensure regulatory standards are met across QA processes.

The role requires knowledge of parenteral product inspection, FDA guidelines, and GMP practices, with proficiency in MS Office and Master Control. OT hours and weekend work may be required.