Microbiology Analyst

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Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Overview:
Microbiology Analysts of all experience levels are encouraged to apply. The Agawam site is the microbiology center of excellence for the Cambrex organization. Microbiology Analysts are responsible for a variety of daily Microbiology laboratory operations to meet established testing requirements and turnaround time commitments to our medical device, pharmaceutical and biotechnology customers.

Responsibilities:
Apply a variety of microbiological techniques to testing as assigned; including but not limited to pour-plating, membrane filtration, dilutions, basic staining, growth promotion testing, plate enumeration, and morphological assessmentPerform testing per written instruction on a variety of internal and client sample types for a variety of tests (i.e.: Bioburden, Sterility, Endotoxin, Mycoplasma, Cytotoxicity, Antibiotic Assays, Microbial Identification via MALDI-TOF or genetic analysis, etc.)Experienced analysts provide expertise in the design of custom microbiological studiesExecute method validation / suitability studies on a variety of tests and/or samples. Adequately document all lab testing performed to GDP standardsAdhere to cGMP rules and regulations as well as applicable written Standard Operating Procedures (SOPs) and technical guidance documents as they apply to the site. Experienced analysts draft protocols, test methods, reports, SOPs and other technical documents Communicate and interact appropriately and effectively will clientsAssist the quality department with investigations and auditsExperienced 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 standardsMaintain an orderly and safe working environment

Qualifications:
Associate's degree in a life science or related field with 3+ years of laboratory (industry) experience (or equivalent). Bachelor's Degree in a life science or related field with 1+ years laboratory (industry) experience.Master's degree in a life science or related field Familiarity in USP/EP/JP and AAMI/ISO guidelinesWell-developed aseptic techniquesSkills and AbilitiesStrong attention to detailPositive attitudeEffective communication skillsWork efficiently to maintain timelines for projects and testingWork as part of a teamWillingness to learn new tests and skillsCambrex 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.