Quality Control Chemist

The Quality Control Chemist is an individual contributor who performs testing of samples of various types using various techniques or equipment in the QC laboratory.

Duties and Responsibilities

• Preparation of protocols and execution of analytical method validation / verification / method transfer.

• Working knowledge on cleaning validation (residue analysis).

• Conduct routine testing or other analysis in a specific group or department setting.

• Conduct advanced testing and/or critical testing, as required.

• Operate specialized equipment or conduct specialized skill testing

• Working knowledge of raw materials testing and release

• Working knowledge of instruments such as Karl Fisher, HPLC, GC, Particle size, ICP

• Lead investigation activities.

• Ensure compliance to all data integrity and cGMP practices, procedures, and expect

• Ensure compliance with all good documentation practices.

• Other duties and responsibilities as assigned by the Head of the Department or Section Head

Education and Experience:

• Bachelor's degree (BS or BA), physical sciences, Chemistry preferred

• Proficiently speak English as a first or second language Proficiently communicate and understand (read and write) scientific work in English

• Must be authorized to work permanently in the United States without company sponsorship

Have excellent organization, learning and teaching skills required to work in teams

• Ability to understand and analyze complex data sets.

• Working knowledge of Microsoft Office programs and other scientific based software.

• Experience in Inhalation products (MDI) is a plus

Working conditions

This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility is required. The role may be assigned on a work-shift basis, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required.

Physical requirements •

Work standing or walking unassisted for 75% or greater of an 8-hour period.

Unassisted lifting up-to10 kg, may be required.

• Able to wear appropriate personal protective equipment at all times, when required.

• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Professional and Behavioral Competencies

• Must be willing to work in a pharmaceutical packaging setting.

• Must be willing and able to work any assigned shift ranging from first or second shift. Work schedule may be Monday to Friday.

• Must be willing to work some weekends based on business needs as required by management.

• No remote work available