The Scientist 1 - Quality Control role performs routine analytical testing on raw materials, intermediate, and final products as well as in-process testing; performs data entry; draft deviations, and participates in OOS investigations for their testing.  Ensures compliance with applicable Company SOPs and regulatory guidance’s.

Responsibilities

• Perform routine testing of raw materials, intermediate, and final products (may include stability)
• Provide support to the plant by performing in-process testing and analyzing cleaning samples.
• Maintain laboratory notebook.
• Ensure equipment is left in good working order after use.
• Perform laboratory upkeep (wash glassware, reorder supplies, check for expired chemicals).
• Draft their deviations.
• Be an active participant in their laboratory investigations.

Qualifications/Skills

Analytical Chemistry Knowledge: Some understanding of the principles of Analytical Chemistry or Quality Control

Cross Discipline Knowledge: Early practical industry exposure to cross functional technical departments, including organic chemistry

GMP/Regulatory Knowledge: With less manager supervision, able to better understand need for SOPs and basic regulatory guidance

Instrumentation: Basic understanding of key analytical R&D equipment, can operate independently once instructed

Communication: Good oral and written communication skills

Problem Solving: May be asked to support peer-led laboratory investigation process with manager support

Time Management: Ability to handle key assignments, with supervision

Leadership: Shares ideas with peers

Technical Documentation and Review: Ability to keep a good laboratory notebook and perform data entry, compliance with GDP

External Influence: Ability to work within a matrix team

Industry Credibility and Rapport: Willing to learn and grow within the local Cambrex Team

Operational Excellence: Strives to engage in group/team improvement projects

Change Orientation: Able to understand the importance of Cambrex initiatives

Education, Experience & Licensing Requirements

M.S. in Chemistry or related field  or B.S. degree in Chemistry or related field with 2 years minimum experience, or Technical Degree with 4 years minimum experience, or High School Degree with 6 years minimum experience.

Experience with and fundamental understanding of several of the following analytical technologies

(* - most important):

• HPLC*
• FTIR*
• Titration
• Basic wet chemistry*
• NMR
• XRPD
• cKF

Working knowledge of other analytical equipment common to the pharmaceutical industry

This position works with and handles hazardous materials and wastes at Cambrex. This person has the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes. He/She is also responsible for recognizing emergency situations concerning hazardous materials and wastes.