Quality Assurance Scientist - AnalyticalCambrex

Cambrex


Quality Assurance Scientist - Analytical

US-NC-High Point

Job ID: 2026-4638
Type: Regular Full-Time
# of Openings: 1
Category: Quality Assurance
Cambrex - High Point

Overview

Perform daily QA activities to support GMP Analytical projects, nonGMP/GMP Manufacturing Facility operations, and other duties as notified by management.

Responsibilities

► Perform approval process for analytical procedures.

► Perform approval process for analytical protocols/reports. Maintain controlled documents.

► Perform approval and release of regulated raw materials and intermediates.

► Review and approve analytical data used in the support of raw material, intermediate, and final product batch release.

► Knowledge and use of computerized quality systems such as Empower, MasterControl, TrackWise, and SAP.

► Develop and issue Certificates of Analysis.

► Assist with management and issuance of notebook system.

► Ensure compliance with company policies and SOPs, as well as FDA and other applicable guidelines.

► Assist with developing and maintaining Cambrex’s quality system.

► Assist with developing and performing training activities.

Occasional Duties:

► Assist with development and writing of standard operating procedures.

► Serve as a backup to Senior Quality Assurance Scientist and management.

► Other duties as assigned and/or developed by Quality Management.

► In the absence of Manager/Associate Director, Quality, sign certificates and forms following

written authorization from management

Qualifications / Skills

► Assist with development and writing of standard operating procedures.

► Serve as a backup to Senior Quality Assurance Scientist and management.

► Other duties as assigned and/or developed by Quality Management.

► In the absence of Manager/Associate Director, Quality, sign certificates and forms following

written authorization from management

Qualifications

 

BS or MS in Chemistry (or closely related discipline) or relevant experience. A minimum of 5 years of relevant background in GXP compliant pharmaceutical laboratory environment or related quality area.

Ability to create and interpret SOPs. Ability to work with minimal supervision.

Equal employment opportunity, including veterans and individuals with disabilities.

PI281674221