Job ID: 2024-3977 Type: Regular Full-Time # of Openings: 1 Category: Quality Control Cambrex - Charles City
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
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
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
