Pharmaceutical Quality Control Chemist

Garonit Pharmaceutical, Inc. (formerly Lab Express, Inc.); Fairfield (NJ); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company is seeking a QC Analyst in Fairfield, NJ. The role involves sampling, inventory management, and compliance with quality standards in a GMP environment. Ideal candidates will hold a Bachelor's degree and possess strong attention to detail and communication skills.

Qualifications

• Bachelor’s degree in Chemistry preferred, recent graduates welcome.
• Experience in FDA-regulated environment is a plus.
• Knowledge of USP monographs, CFR, and ICH guidelines.

Responsibilities

• Perform HPLC, GC sample preparation and testing.
• Manage chemical inventory and waste disposal.
• Support laboratory investigations and validations.

Skills

Attention to detail

Communication

Interpersonal skills

Self-motivation

Education

Bachelor’s degree in a scientific or technical discipline

Tools

HPLC

GC

Waters Empower

Job description

Garonit Pharmaceutical, Inc. (formerly Lab Express, Inc.) Fairfield, NJ

3 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

The QC Analyst is responsible for the day-to-day sampling and inventory in the QC lab and related duties. All duties are performed in compliance with established regulatory, compendial, and internal quality standards to support Validation and Stability, and to maintain lab equipment, instruments, and inventory. The QC analyst works closely with the Quality team members, QC Manager, and Quality Assurance in all aspects of quality systems compliance and continuous improvement.

Responsibilities

1. Perform HPLC, GC, etc. sample preparation and testing.
2. Review, interpret, analyze, and report data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines.
3. Clean, maintain, and troubleshoot instruments.
4. Perform compendial monograph testing and Garonit-specific tests.
5. Assist in developing and validating non-compendial testing as needed.
6. Ensure lab safety and manage chemical inventory.
7. Train and develop other chemists.
8. Audit work of other chemists.
9. Daily balance and pH calibration.
10. Log all incoming samples.
11. Manage chemical inventory and waste disposal.
12. Prepare samples for customers, contract lab testing, and stability studies.
13. Manage QC sample and retain inventories.
14. Sample and test incoming raw materials, in-process, finished product, and packaging materials.
15. Perform wet chemistry tests following procedures and methods as required.
16. Work with contract laboratories and service providers.
17. Support laboratory investigations, CAPA, change controls, validations, stability programs, statistical analysis, environmental monitoring, etc.
18. Conduct water sampling and microbial swabbing.
19. Complete all GMP logs, documents, and forms.
20. Perform additional laboratory duties as needed.
21. Other duties assigned by management.

Qualifications

• Bachelor’s degree in a scientific or technical discipline (Chemistry preferred). Recent graduates are encouraged to apply.

Experience Preferred

• Experience working in an FDA-regulated environment.
• Knowledge of USP monograph testing.
• Knowledge of CFR & ICH regulatory guidelines.
• Knowledge of cGMP processes and lab safety.
• Knowledge of HPLC, GC, and Waters Empower is a plus.

Other Requirements

• Excellent oral and written communication skills.
• Excellent interpersonal skills.
• Self-motivated with a high attention to detail.
• Positive attitude.
• Ability to speak, read, and write in English.
• Able to lift 25 pounds and stand for extended periods.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance

Get notified when a new job is posted. Sign in to set job alerts for “Quality Control Chemist” roles.

Other recent postings include roles in Wharton, NJ, New York, NY, Morristown, NJ, Edison, NJ, Passaic County, NJ, Rahway, NJ, Chestnut Ridge, NY, Flanders, NJ, Clark, NJ, among others.