Quality Assurance Scientist - Analytical

Job Description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Job 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

Education, Experience & Licensing Requirements

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.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.