Quality Control, Chemist I

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