The Quality Control Analyst performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods ensuring compliance with established standards. This role supports the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, and local and global Quality Management Systems (QMS). Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standardsParticipate in method validation and method transfer activitiesConducts and validates various biological and chemical quality control (QC) assaysWrite, revise and/or review Standard Operating Procedures while adhering to regulatory requirementsMaintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelinesTroubleshoot equipment problemsRecognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation processMaintain cGMP compliance in the laboratoryMay require work on various projects to improve efficiency or complianceAdditional responsibilities may be assigned by Supervisor or Manager as needed to support the OrganizationFollows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDR, and compliance to the site Quality ManualOther duties as assigned



Who You Are:




Minimum Qualifications:



Bachelor's Degree in Biology, Microbiology, Immunology, or other life science field



Preferred Qualifications:



3+ years' experience in an FDA/ISO regulated environmentKnowledge of FDA QSRs, cGMP, and ISO 13485 or other industry standardsKnowledge and experience in IHC, ELISA, and Bioburden Knowledge of SAP and/or SAP NEXTExcellent communication skills, both written and verbalRSREMD