AVISTA PHARMA SOLUTIONS INC Dba CAMBREX Hiring for Technical Reviewer at Longmont, Colorado Full Time

CambrexLocations: Longmont, ColoradoCategories: Quality AssuranceReq ID: 2563OverviewThe Technical Reviewer will work independently within a team to provide atechnical data review for laboratory testing data in compliance with GMPstandards and FDA / ISO regulations. This position specializes in variousaspects of technical data and documentation evaluation and review,laboratory investigations, and a variety of routine and non-routine qualityassurance tasks.Responsibilities- As Technical Reviewer, you will be primarily responsible for performing anindependent technical review of all test results and data for completeness,accuracy and compliance.- Scope: All analytical GxP testing performed in theanalytical laboratories at the Longmont, CO facility. – Method: Ensure alltesting was performed per approved SOPs/methods/protocols by criticallyanalyzing the reported data and results for accurate interpretation andconclusion. Ensure all issues/documentation is complete prior to approval.-Timeline: Provides accurate and timely delivery of data review and reportany adverse findings to the appropriate departments to support overall projectdue dates.- As a Technical Reviewer, may assist in laboratoryInvestigations.- Scope: Out of specification (OOS) and aberrant resultlaboratory investigations.- Method: Work with analyst and laboratorymanagement to ensure investigations are completed per approved testing plans.- Timeline: Support timely closure of the laboratory investigation asrequired by procedure by ensuring testing is reviewed promptly. Escalateissues which may impact timeline to laboratory and quality management.Qualifications- Requires Bachelor’s Degree in Biochemistry, Chemistry, Biology orrelated field.- 6+ years of laboratory testing experience, preferably inthe pharmaceutical or biotechnology industries.- Experience working in GMPtesting environment.- Knowledge and experience with a wide variety ofanalytical techniques such as HPLC, GC, FT-IR, ICP, NMR, UV/Vis,Karl Fischer.SUCCESS FACTORS:- Experience working with LIMS and Empowerpreferred.- Demonstrated ability to work collaboratively in a teamenvironment.- Demonstrated ability to think critically and to focus on detailsof execution.- Demonstrates ability to work effectively on problems of adiverse scope and with analysis/evaluation of data.- Expertise with respectto demonstrating theoretical understanding and providing effective evaluationof laboratory practices and methods including compendial methods.- Experiencein authoring, revising, reviewing technical documents such as methods,reports, and protocols.- Experience in participating and supportingregulatory inspections through explanations of methodologies,investigations, and/or laboratory systems is preferred. The hiring rangein Colorado for this position is $70,000-$81,000; however, basepay offered may vary depending on job-related knowledge, education, skillsand experience of the applicant, internal equity, and alignment withmarket data. This information is provided per the Colorado Equal Pay Act. Thisposition includes a competitive benefits package. Cambrex is an EqualOpportunity / Affirmative Action employer and will consider all qualifiedapplicants for employment without regard to race, color, religion,gender, sexual orientation, gender identity, national origin, age, protected veApply Here: https://www.click2apply.net/V7PKdyCknXL4GfZArUJVoMPI174916128