Job Description

Our client, a growing pharmaceutical company, is looking for a skilled QC Analyst to join their team in Kalamazoo County, MI!

Job Title: QC Analyst

Department: Quality Control

Pay rate: $30/hr. - $34/hr.

Location: Kalamazoo County, MI

Job Type: Contract- hire

Job Summary

The QC Analyst ensures the accurate and timely execution of laboratory analyses in accordance with cGMP standards. This role supports the development and validation of new analytical methods and is responsible for the proper scheduling and coordination of laboratory activities to ensure compliance and efficiency.

Key Responsibilities

• Maintain the Quality Control Laboratory in a state of compliance with current Good Manufacturing Practices (cGMP).
• Perform QC testing for raw materials, in-process samples, intermediates, cleaning verification/validation, and final product release.
• Participate in the development and validation of analytical methods.
• Review laboratory data, documentation, and control records for accuracy and completeness.
• Write, review, and revise Standard Operating Procedures (SOPs) and material specifications.
• Support Quality Assurance during internal, customer, and regulatory audits.
• Participate in Out-of-Specification (OOS) and deviation investigations, providing analytical support to QA.
• Assist with execution of laboratory equipment qualification and calibration.
• Manage and maintain inventory of reagents, standards, and reference materials.
• Support the stability testing program, including performance of tests and evaluation of trends.
• Issue Certificates of Analysis (CoAs) for tested materials/products.
• Collaborate with cross-functional teams to resolve technical issues and improve laboratory processes.
• Develop technical knowledge and independence through mentorship and hands-on training.

Qualifications

• Bachelors degree in Chemistry or a related scientific discipline is required.
• Minimum of 4 years in a GMP-regulated pharmaceutical or biopharmaceutical environment.
• At least 2 years of experience in a Quality Control laboratory preferred.
• Proficient in laboratory techniques with strong attention to detail.
• Ability to perform testing independently and document results accurately.
• Familiar with analytical instruments (e.g., HPLC, GC, UV-Vis) and troubleshooting techniques.
• Understanding of cGMP, GLP, and other regulatory requirements.
• Strong written and verbal communication skills.
• Excellent organizational and time management abilities.
• Capable of working both independently and as part of a team.

Note: This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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