Overview:

The Chemist I in Quality Control is responsible for performing a variety of chemical analyses to ensure the release of raw materials, intermediates, and finished products. The role requires adherence to EPA, FDA, cGMP, cGLP, and DEA regulations, as well as company SOPs. The Chemist I also contributes to the development and maintenance of laboratory programs, such as stability testing, calibration, and preventive maintenance, and participates in method development and troubleshooting for analytical instruments. The position involves handling hazardous materials, conducting statistical evaluations of data, and providing on-call support as needed.

Responsibilities:

Adhere to all EPA, FDA, cGMP, cGLP DEA regulations and internal SOP's as they relate to the operation of the Quality Control lab and general operation of the chemical production facility

Follow all OSHA and company safety rules and practices

Data review

Data entry

Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability

Maintain/support laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ

Perform in-depth laboratory investigations of non-complying test results.

Working knowledge of chromatography

Working knowledge of wet chemistry

Write controlled documents such as reports, test procedures, SOPs, etc.

Evaluate validity of test results

Independently troubleshoot equipment

Perform and document method transfer from Analytical Development

Run method evaluation experiments

Handle, analyze and dispose of hazardous samples and waste

Provide off-shift coverage as required

Maintain laboratory solutions, inventory and notebooks

Responsible for assisting in training employees as needed both inside and outside the department

Coordinate and communicate project status

Interacting with outside vendors and other departments

Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at Cambrex Charles City.

Proven ability to handle various assignments and organize workload to meet timelines

Act as departmental subject matter expert (SME)



All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications / Skills::

Strong cGMP experience

Experience testing against USP and EP compendia.

Working knowledge of analytical instrumentation (GC, HPLC minimum)

Working knowledge of NMR, DSC, IC, and/or ICP-OES preferred

Strong chemistry theory

Proven ability to handle various project load is preferred

Ability to work in a fast-paced, deadline driven work environment

Strong attention to detail

Effective communication skills (oral, written)

Ability to work well with others in a team environment

Ability to work independently with little or no direct supervision

Mass Spectrometer experience preferred

Qualifications:

BS/BA in Chemistry/Biology or related science field required

Advanced degree (MS, PhD) in Chemistry/Biology or related science field preferred

Three years laboratory cGMP environment (preferred NLT 5 years) with a BS or advanced degree