The Histology Associate Analyst is responsible for proficiently performing and documenting histological testing per standard operating procedures. This individual will provide histology support for the Quality, R&D, Clinical, Complaints, and Tissue Services Departments. Functions include all phases of tissue preparation, including paraffin and frozen technique, routine H&E (Hematoxylin & Eosin) staining, and special stains (histochemisty). This individual is also responsible for maintenance and operation of histology equipment; as well as supporting equipment validations, document/procedural revisions, training technicians, laboratory investigations, and audits. The Associate Analyst may have an opportunity to learn specilized techniques such as immunhistochemistry, microscopy and image analysis; and be involved in process improvement projects.
Specimen preparation that requires a complex and thorough understanding of tissue structure, as well as a basic understanding of chemistry and physics; and how tissues react under process conditions, including decalcification, rehydration, grossing, fixation, embedding, microtomy, routine staining and special stains (histochemistry). This requires the ability to analyze stain results for accurate and appropriate staining, and to discern if false results were induced through the production process, or are artifacts through the histological testing process.
Proficiently performs Histology testing and analysis, as well as testing R&D, Clinical, and donor samples. Collaboration with other histology analysts, Medical Directors and Scientists in examining test samples and applying gross anatomy understanding in conjunction with the study purpose to dissect appropriate representative samples and tissue orientation for histology testing and analysis. This individual may also analyze test samples, make recommendations on product suitability, and when appropriate, report aberrant test results.
Preparation of reagents and solutions for fixation and stain techniques. Operate, maintain, and assist in qualification/validation activities of standard laboratory/histology equipment (microtome, cryostat, tissue processor, embedding units, stainer/coverslipper, balances, incubator, waterbath, microscope, etc.) as required.
Understand and act on department/project objectives; and participate in process improvement projects, in a time sensitive and project oriented fashion. Update standard operating procedures as needed. Participate in the training and development of others.
Follow Laboratory Safety Standards, proper Biohazard & Chemical Waste Disposal, and comply with current Good Manufacturing, Good Laboratory and Good Documentation Practices. Adhere to company work standards and Code of Conduct. Diligently participate in compliance-related activities, support audits/inspections and the overall quaality system as denoted by management.
4-6 years histology laboratory experience
1-3 years in histochemistry (Special Stains)
Cell Biology and Tissue Structure knowledge
Laboratory & Chemical safety, and Blood Borne Pathogens training
Computer Skills: Microsoft Word, Excel, Powerpoint, Outlook required
Teamwork and Interpersonal Skills. Ability to communicate effectively both verbally and written with all levels of management, internal/external customers, vendors, and those of diverse cultures
Basic Mechanical skills and lifting up to 20 lbs
Good visual skills, manual dexterity and eye-to-hand coordination
Ability to follow SOP’s and Work Instructions with attention to detail
Strong math skills, aptitude for analysis, and technical writing
Microscopic and Image analysis experience
GDP training; and experience in working in a GMP, GCP, or GLP environment.
Familiar with AATB, ISO, FDA, and USP regulations/guidelines, and audits.
Technical Certification (HT, HTL, QIHC, or related) preferred/eligible
1year immunohistochemistry experience preferred
B.S. in Biology or related science or equivalent years of work experience is required
Internal Number: 193611
model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.