Quality Control Analyst

AL Solutions; New Jersey; On-site; USD 70,000 - 90,000; Full time

Job summary

A pharmaceutical manufacturing company is seeking a QC Analyst to support clinical and commercial programs by conducting analytical testing in compliance with regulatory standards. The ideal candidate will have at least 3 years of experience in a GMP environment and expertise in techniques like HPLC and ELISA. This full-time position requires a bachelor's degree in a related field and offers a dynamic work environment.

Qualifications

• Minimum of 3 years of hands-on experience in a GMP-compliant QC laboratory environment.
• Proficient in key analytical techniques including HPLC, SDS-PAGE, ELISA, and Capillary Electrophoresis.

Responsibilities

• Conduct analytical testing for in-process, raw materials, release, and stability programs.
• Ensure compliance with cGMP, ICH guidelines, and internal Quality Systems.
• Participate in investigations related to Out-of-Specification results.

Skills

Analytical Testing

Protein Chemistry

HPLC

SDS-PAGE

ELISA

Capillary Electrophoresis

Education

Bachelor’s degree in Biotechnology, Biochemistry, Chemistry, or related field

Job description

Overview

The QC Analyst will support late-stage clinical and commercial programs by performing and reviewing analytical testing in a cGMP-regulated environment. This position requires strong technical expertise in protein chemistry and proficiency with a range of analytical methods to ensure product quality and regulatory compliance.

Responsibilities

• Conduct analytical testing for in-process, raw materials, release, and stability programs in accordance with established SOPs and regulatory requirements.
• Ensure full compliance with cGMP, ICH guidelines, and internal Quality Systems.
• Participate in and support investigations related to Out-of-Specification (OOS) results, deviations, and development of CAPA plans.
• Collaborate cross-functionally to support project execution, equipment qualification, and documentation of analytical data and reports.
• Assist in regulatory inspections and internal audits by providing data, documentation, and subject matter expertise.
• Maintain a high level of data integrity and ensure timely, accurate completion of laboratory documentation.
• Carry out additional responsibilities as needed, in alignment with company policies and procedures.

Experience

• Minimum of 3 years of hands-on experience in a GMP-compliant QC laboratory environment.
• Proficient in key analytical techniques including:
• HPLC
• SDS-PAGE
• ELISA
• Capillary Electrophoresis

Education

• Bachelor’s degree in Biotechnology, Biochemistry, Chemistry, or a closely related field.

Additional information

• Seniority level: Associate
• Employment type: Full-time
• Job function: Science
• Industries: Pharmaceutical Manufacturing