QA Operations Specialist — 3rd Shift (FDA-Regulated)

Corium Innovations; Grand Rapids (MI); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, vision

Flexible spending accounts

Life insurance

Disability insurance

Employee assistance program

401(k) with company match

12 paid holidays

Vacation and shutdown leave

Job summary

Corium Innovations is seeking a Quality Assurance Operations Specialist for the 3rd shift (10pm–6am, Monday–Friday) to support QA operations on the manufacturing floor. This role requires strong knowledge of cGMP, GDP, and FDA guidance documents, with a focus on accurate record-keeping and timely issue resolution.

The ideal candidate will have a science degree and at least 2 years of related experience in a FDA-regulated environment, plus excellent interpersonal skills to collaborate with

Qualifications

• Requires knowledge of Quality Assurance principles and cGMP regulations.
• Familiarity with FDA guidance documents and regulatory submission requirements is preferred.
• Ability to maintain accurate records and communicate clearly with manufacturing teams.

Responsibilities

• Provide on-the-floor quality oversight of manufacturing operations for commercial and development projects.
• Review executed manufacturing records for GDP and cGMP compliance.
• Review documentation and authorize release of raw materials, WIP, and finished goods.

Skills

Quality Assurance

cGMP

FDA regulations

Record keeping

Attention to detail

Interpersonal skills

Education

Bachelor’s Degree in Science

Job description

Corium Innovations is seeking a Quality Assurance Operations Specialist for the 3rd shift (10pm–6am, Monday–Friday) to support QA operations on the manufacturing floor. This role requires strong knowledge of cGMP, GDP, and FDA guidance documents, with a focus on accurate record-keeping and timely issue resolution.

The ideal candidate will have a science degree and at least 2 years of related experience in a FDA-regulated environment, plus excellent interpersonal skills to collaborate with