Pharma Inspection Line Lead — QC Oversight & Training

Grand River Aseptic Manufacturing Inc.

Grand Rapids (MI)

On-site

USD 55,000 - 75,000

Full time

5 days ago
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Benefits offered by this job

Benefits from day 1
Paid volunteer time
PTO 13 days
Wellness time off
Paid holidays

Job summary

Grand River Aseptic Manufacturing Inc. is seeking an Inspector to oversee inspection operations for parenteral products and support the finishing area.

The role ensures adherence to cGMP, FDA guidelines, and global regulatory standards, while guiding inspectors and maintaining documentation accuracy. Responsibilities include training inspection staff, managing equipment setup, performing inspections, and contributing to continuous quality and safety improvements.

Qualifications

  • 1+ years relevant experience as a qualified inspector of parenteral products.
  • Knowledge of QA principles and procedures in a pharma, biopharma, or biotech manufacturing environment.
  • Experience in pharmaceutical inspection of regulated products with understanding of cGMP, FDA guidelines and multinational regulatory standards.
  • Knowledgeable of GMP standards and ability to follow CFR guidelines.
  • Ability to work overtime and weekends, as necessary.
  • Must have proficient computer skills in Word, Excel and Outlook.

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 set up and operation.
  • Perform Good Documentation Practices with accuracy and according to regulatory guidelines.
  • Assist in completion of batch record materials.
  • Ability to navigate through 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, upward/downward, with all Finishing and cross-functional teams.
  • Actively participate in Continuous Quality and Safety Improvements.
  • Support Agency, customer and vendor audits as needed.

Skills

QA principles
cGMP guidelines
Regulatory compliance
Overtime flexibility

Tools

Microsoft Word
Microsoft Excel
Outlook

Job description

Grand River Aseptic Manufacturing Inc. is seeking an Inspector to oversee inspection operations for parenteral products and support the finishing area.

The role ensures adherence to cGMP, FDA guidelines, and global regulatory standards, while guiding inspectors and maintaining documentation accuracy. Responsibilities include training inspection staff, managing equipment setup, performing inspections, and contributing to continuous quality and safety improvements.

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