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TOLMAR Inc. QA Laboratory Specialist in Fort Collins, Colorado

Purpose and ScopeThe QA Laboratory Specialist is responsible for providing quality oversightfor Tolmar Quality Control laboratories in accordance with company policies,standards, procedures and CGMP. Functional responsibilities include ensuringaccurate and timely review of documents for Quality Control includingspecifications, SOPs, work instructions and qualification documentation.This position will provide compliance oversight for the QC laboratories,ensuring accurate and timely review of laboratory investigations, performinganalysis on quality-indicating data, identifying any trends noted for QCdata and functioning as the quality representative to provide support forlaboratory activities associated with RandD and continuous improvement.Essential Duties and ResponsibilitiesSupport Analytical and Microbiological QC laboratory oversight activities forthe Quality Operations group.Work with laboratory management to ensure laboratory activities comply withregulatory requirements, including data governance and data integrityrequirements.Ensure procedures are adequate to review and confirm appropriateness oflaboratories raw data.Review and approve documentation associated with the laboratories, such asspecifications, procedures, test methods, variances, change controlsand qualification activities.Review and approve of laboratory deviations and minor OOS/OOT investigationsand accompanying CAPAs.Provide compliance oversight of laboratories to ensure alignment with internalcompany policies and procedures.Ensure method qualifications, method transfers, and analyst trainingrequirements meet company and regulatory requirements.Manage the implementation and maintenance of Quality Systems and activitiesrelated to the laboratories.Support audits of Tolmar Quality Systems and Operations.Represent department in internal and external cross-functional teams.Serve as Quality representative and oversight for process improvement projectsand RandD activities in the laboratories.Perform other duties as assigned.Knowledge, Skills and AbilitiesKnowledge in cGMP, 21 CFR 210, 211, 820 and ISO 13485.Independent, organized and able to lead others to meet deadlines.Ability to work in an independent and self-directed manner.Ability to clearly communicate (oral and written) and work well withemployees at all levels.Able to prepare written communications and communicate problems to managementwith clarity and accuracy.Ability to write procedures and reports clearly and accurately.Ability to recognize and group technical/scientific attributes and drivescience-based decisions in most technical areas and to a deeper level in thespecific job function.Ability to critically review investigations and reports, interpretresults, and generate technical conclusions consistent with quality riskmanagement principles.Computer literacy in Microsoft Word, Access, Excel and other MS Officeprograms.Recognized subject matter expert on quality assurance topics within alaboratory environment.Core ValuesThe QA Laboratory Specialist is expected to operate within the framework ofTolmar s Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task.Education and ExperienceBachelor s degree in scientific discipline required.Five or more years of experience in the pharmaceutical industry working in aQC Lab or QA experience supporting the laboratory.Strong understanding of analytical and microbiological methods.Working ConditionsCore hours are from 8 AM 5 PM Monday through Friday, with availabilityto work extended hours on evenings and/or weekends as nec

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