Quality Assurance Compliance Specialist PC 897

Company: Lentigen Technology, Inc.
Location: Gaithersburg
Posted on: March 20, 2023

Job Description:

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.Quality Assurance Compliance SpecialistGaithersburg, MDAs a Quality Assurance Compliance Specialist, you will be responsible for reviewing quality agreements, Master Service Agreements, and Scope of Work Documents to make sure that the client quality expectations are clearly aligned with Lentigen Quality Systems and government regulations for the appropriate clinical phase of manufacturing.Among other responsibilities, you will:Manages the review and execution of client Quality AgreementsCollaborates with internal management team to ensure that all departments are aware of compliance requirements and issuesSupports the Associate Director in leading gap assessments of Lentigen Quality Systems against current US and international regulationsFacilitates the review and approval of deviation reports; ensure appropriate action items are assigned and closed; and prepare and present issue management metricsLeads performance of GMP gap assessments of quality systems and associated improvement plansReviews quality systems to identify gaps and improve quality systems to support commercial manufacturing of vectors and cell therapy productsAct as client liaison to monitor client commitments, provide updates at product team meetings and manage progress of commitments to support Operations Project Management TeamCoordinates completion of issue management s and CAPA closureOrganizes and facilitate Management review meetingsDevelop and manage preparation for site management reviewRequirementsB .S. degree in a Life Science discipline and a minimum of 5 years' experience in quality assurance, quality control and/or GMP compliance; or equivalent combination of education and experience.A minimum of 2 years project management experience or an equivalent combination of education and experienceKnowledgeable in current Good Manufacturing Practice (GMP) regulations, including those for advanced therapies.Proficient in MS Office, including Access, Excel and Word. PowerPoint and Visio knowledge a plus.Must be authorized to work in the U.S.Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more - all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.Lentigen Technology, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender IdentityMiltenyi Biotec, Inc. participates in E-Verify.

Keywords: Lentigen Technology, Inc., Washington DC , Quality Assurance Compliance Specialist PC 897, IT / Software / Systems , Gaithersburg, DC