Company Information
You Matter to Cambrex.
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 more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
- engage in work that matters to our customers and the patients they serve
- learn new skills and enjoy new experiences in an engaging and safe environment
- strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
Reporting to the Manager, QC, the microbiologist is responsible for independently testing finished good API samples, water samples, and environmental monitoring samples for USP <61>, <62>, and <85>. The microbiologist will also maintain to microbiology laboratory, including cleanliness and maintain supplies to perform microbiological testing.
Responsibilities
- Provide microbiology laboratory testing support for the site.
- Follow all OSHA and company safety rules and practices
- Data review
- Data entry
- Perform chemical testing using analytical instrumentation including TOC, conductivity meter, and endotoxin reader.
- Perform testing per USP <61>, USP <62>, and USP <85> for finished good APIs, water, and environmental monitoring samples
- Write and execute microbial methods and validation protocols.
- Adhering to SOPs and regulatory systems as they relate to laboratory testing operations; e.g. cGMP compliance and training
- Communication with supervisors about work status and problems
- Independently track reagent and media inventories
- Perform aseptic repackaging of materials as needed
- Receive and document sample entry into the QC system
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
- High attention to detail
- Ability to handle various project loads and to multi-task
- Ability to independently track and manage microbial testing needs
Education, Experience & Licensing Requirements
- High school education required, an AS/AA or BS/BA is preferred
- Minimum of 3 years of microbial testing experience. NLT 5 years of microbial testing experience is preferred.
- Ability to lift and move items up to 25 pounds.
- Must be able to perform tasks requiring physical mobility, including standing for long periods, bending, and reaching.
- Exposure to chemicals, moving parts, vibration, and noise within a laboratory setting.
- May require occasional travel for training or method transfer activities.
- Flexible to work different shifts if necessary to meet critical deadlines.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
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