Cambrex · 1 day ago
Quality Assurance Scientist - Analytical
High Point, NC
Full-time
Onsite
Senior Level
5+ years expCambrex is a leading global contract development and manufacturing organization that specializes in drug substance development and manufacturing. The Quality Assurance Scientist will perform daily QA activities to support GMP Analytical projects and ensure compliance with company policies and FDA guidelines.
AnalyticsBiotechnologyInnovation ManagementManufacturingMarket ResearchPharmaceutical
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
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
Qualification
Required
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
Benefits
Healthcare
Life insurance
Planning for retirement
Company
Cambrex
Cambrex is a small molecule company that offers drug substance, drug product, and analytical services.
1001-5000 employees
H1B Sponsorship
Cambrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (19)
2023 (16)
2022 (15)
2021 (7)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
unknown2019-08-07Acquired
1987-10-02IPO
Leadership Team
Tom Loewald
Chief Executive Officer
Robert Green
EVP & Chief Financial Officer
Recent News
Company data provided by crunchbase