Technical Data Reviewer

Company: Cambrex
Location: Agawam
Posted on: March 17, 2023

Job Description:

Job Description:

Company Information\n\n* You Matter to Cambrex. *\n\n 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 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. \n\n* Your Work Matters. *\n\n At Cambrex, we strive to build a culture where all colleagues have the opportunity to: \n\n* engage in work that matters to our customers and the patients they serve \n* learn new skills and enjoy new experiences in an engaging and safe environment \n* strengthen connections with coworkers and the community \n\n 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 medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., that includes healthcare, life insurance, planning for retirement, and more! Will need to confirm with Mirko for Italy; Barbara for Canada; Emma for Sweden-Estonia-Germany; Rose for Scotland and Ireland. \n\n* Your Future Matters. *\n\n 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! \n \nJob Overview\n\nThe Technical Reviewer will work independently within a team to provide a technical data review for laboratory testing data in compliance with GMP standards and FDA / ISO regulations. This position specializes in various aspects of technical data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine quality assurance tasks. \n\nResponsibilities\n\n\n* As Technical Reviewer, you will be primarily responsible for performing an independent technical review of all test results and data for completeness, accuracy and compliance. \n\n* Scope: All Microbiological and Environmental Monitoring GxP testing performed in the laboratories at the Agawam, MA facility. \n* Method: Ensure all testing was performed per approved SOPs/methods/protocols by critically analyzing the reported data and results for accurate interpretation and conclusion. Ensure all issues/documentation is complete prior to approval. \n* Timeline: Provides accurate and timely delivery of data review and report any adverse findings to the appropriate departments to support overall project due dates. \n* As a Technical Reviewer, may assist in laboratory Investigations. \n\n* Scope: Out of specification (OOS) and aberrant result laboratory investigations. \n* Method: Work with analyst and laboratory management to ensure investigations are completed per approved testing plans. \n* Timeline: Support timely closure of the laboratory investigation as required by procedure by ensuring testing is reviewed promptly. Escalate issues which may impact timeline to laboratory and quality management. \n \nEducation, Experience & Licensing Requirements\n\n\n* Requires Bachelor's Degree in Biology, Microbiology, or related science field. \n* 6+ years of laboratory testing experience, preferably in the pharmaceutical or biotechnology industries. \n* Experience working in GMP testing environment. \n* Knowledge and experience with a wide variety of Microbiological techniques including but not limited to Sterility testing, Bioburden testing, Microbial Limits, Endotoxin, and Microbial ID. \n\n \n * SUCCESS FACTORS: * \n\n* Experience working with LIMS preferred. \n* Demonstrated ability to work collaboratively in a team environment. \n* Demonstrated ability to think critically and to focus on details of execution. \n* Demonstrates ability to work effectively on problems of a diverse scope and with analysis/evaluation of data. \n* Expertise with respect to demonstrating theoretical understanding and providing effective evaluation of laboratory practices and methods including compendial methods. \n* Experience in authoring, revising, reviewing technical documents such as methods, reports, and protocols. \n* Experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems is preferred. \n\n 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. \n\n#cb #LI-LS1

Keywords: Cambrex, Springfield , Technical Data Reviewer, IT / Software / Systems , Agawam, Massachusetts