QC Technician

Employer
Apex Systems
Location
Severn, MD
Posted
Jul 28, 2021
Closes
Jul 30, 2021
Ref
2141215546
Hours
Full Time
Apex Systems has an immediate need for a QC Technician in the Harmans, MD area. This role is responsible for supporting compliance in the Quality Control Laboratory, including authoring, management and/or tracking of investigations/events/deviations, Corrective Action / Preventive Action (CAPA), change control, and other Quality records. If interested or would like more information please send your updated resume to: Korena at kshaw@apexsystems.com Responsibilities of QC Technician: Complete Quality Records investigations that meeting both Industry and client expectations Initiate and complete the write up and closure of Investigations, Deviations and Change Controls. Leads or manage investigations including root cause analysis and assesses product impact using input from various departments Develops, executes and oversees CAPAs Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective. Assists with the generation and/or revision of GMP documentation such as standard operating procedures. Participate in site quality and process improvement initiatives. Represent QC Department on site project teams. Participates in QC internal audits as applicable. Requirements of QC Technician: Bachelor's degree in a science or engineering field, preferred 2+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (eg Quality Control, Quality Assurance, Production, Technical Services or related field) 2-5 years of experience within the biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory 1-2 years of experience in Quality / Compliance function, in completion of deviation investigations and remediation or significant participation with investigations/deviations/events/etc., within a laboratory setting Experience with the analytical and/or bioanalytical testing process and/or EM Microbiology laboratory settings, preferred Ability to perform investigation-related interviews and familiarity with root cause analysis Previous experience authoring and/or revising technical documents For immediate consideration, send your most up-to-date resume to: Korena at kshaw@apexsystems.com EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178

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