Job Title: Medical Laboratory Technologist IIJob Description As a Medical Laboratory Technologist II, Technical Specialist, you will ensure a strong GMP environment within a dynamic and changing manufacturing/quality environment. You will achieve compliance readiness in each laboratory area and serve as the main point of contact for Laboratory Services. This includes coordinating training for new and incumbent employees on equipment, documentation, product control, handling, storage, serological duties, chemistries, and any other tasks to ensure products reach customers. You will assist with reviewing and approving test data, preparing validation documents, writing, reviewing, and creating SOPs and OJTs, and overseeing special projects. Responsibilities + Serve as the Medical Technologist Technical Specialist to ensure alignment of the labs with qualification of antisera. + Act as a technical writer for SOPs, OJTs, and documentation of training metrics for lab services. + Perform administrative tasks including recording test results according to department procedures, quality plans, device history records, and work instructions, and assist with the review of generated records. + Participate in the internal audit process. + Assist with special projects such as Surveys and Validations and other duties as assigned. + Perform department Technical Review of documents prepared in the laboratory. + Assist with training of identified trainers in each laboratory. + Assist in training, retraining, and competency assessment of employees. + Create legible, complete, and accurate records according to procedure/work-instruction-defined protocols, time frames, and according to Current Good Manufacturing Procedures (cGMP’s). + Follow applicable laboratory SOPs, OSHA regulations, and cGMP regulations including Chemical hazards and blood-borne pathogens. + Understand FDA and ISO standards applicable to the department and the consequences of nonconformance. + Understand the source, composition, and characteristics of products and associated chemical and biosafety hazards. + Maintain a polite, helpful, and professional manner with employees within and outside of the department. + Support the implementation of metrics and drive the performance of the metrics. + Participate in the SOP review and revision process. Essential Skills + Bachelor’s Degree in Medical Technology, Life Sciences, or other science or technical field + 1-3+ years of professional experience working in a blood bank environment + MT(ASCP) or equivalent (preferred) + 1+ years of experience in a highly regulated/GMP environment + Experience with medical device regulatory documentation + Knowledge of EUMDR and FDA standards + Technical writing experience + Proficiency in creating and reviewing SOPs Additional Skills & Qualifications + Ability to read, analyze, and interpret complex documents + Strong mathematical, analytical, and problem-solving skills + Excellent communication skills, both written and verbal Work Environment This position follows a Monday to Friday evening shift schedule from 1:00 PM to 9:30 PM. The work environment involves working with laboratory equipment and adhering to safety protocols, including those related to chemical hazards and blood-borne pathogens. The role requires maintaining a professional demeanor and collaborating with team members in a regulated environment. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.