Analytical Analysts are responsible for a variety of daily Analytical laboratory operations to meet established testing requirements and turnaround time commitments to our medical device, pharmaceutical and biotechnology customers.
Responsibilities
Apply a variety of analytical techniques to testing as assigned; including but not limited to: instrumental analysis, gravimetric analysis, titration, appearance, identification, and a wide variety of wet chemistry techniques.
Perform testing per written instruction on a variety of internal and client sample types for a variety of tests (i.e. TOC, conductivity, pH, osmolality, container closure integrity, subvisible particulate, FT-IR, Karl Fisher, GC, HPLC, and a vast array of compendial analyses, etc.)
Experienced analysts provide expertise in the design of custom analytical protocols and studies
Execute method validation / suitability / verification / transfer studies on a variety of tests and/or samples.
Adequately document all lab testing performed to GDP standards
Experienced analysts draft protocols, test methods, reports, SOPs and other technical documents
Communicate and interact appropriately and effectively with clients
Assist the quality department with investigations and audits
Experienced analysts stay abreast of industry trends and current technology, design and implement process improvements, recommend strategic investments in equipment, and train other analysts to current standards
Maintain an orderly and safe working environment
Responsible for ensuring all testing is completed in a timely manner, following written procedures in a cGMP compliant environment, and managing quality events.
Ensure the laboratory is maintained in an audit ready state, review data for accuracy and completeness, and write technical documents (e.g. reports, protocols, test procedures, SOPs, etc.).
Qualifications
Bachelor’s Degree (or advanced degree) in Chemistry or related science field required.
1+ years of experience in a GMP analytical chemistry testing laboratory.
Experience supporting compendial testing (USP, EP, JP, ACS, FCC, etc.) for wet chemistry, chromatographic, and spectrophotometric analyses.
Experience performing root cause analysis for quality events
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
