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Description:
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, special stains (histochemisty), microscopy and image analysis. This individual is also responsible for maintenance, operation, qualification/validation of histology equipment, document revisions, training technicians and peers in histological sample handling, stain technique, and digital imaging. The Associate Analyst may have an opportunity to develop/learn specialized techniques such as immunhistochemistry; and be involved process improvement projects and standard operating procedure/document revisions.
- Proficiently performs Histology testing for QC product release test samples, Clinical (complaint) cases, donor samples, R&D, and engineering studies.
- 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, special stains (histochemistry), and immunohistochemistry as applicable with skillset and training.
- Analyze stain results for accurate and appropriate staining, and to discern if staining is appropriate or if false results were induced through the histological testing process.
- Acts as the final quality check on product prior to product release, by proficiently performing Histology analysis. This requires the ability to analyze stain results to discern if false results were induced through the histological process or if the findings resulted from the production process.
- 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.
- Peer review of sample preparation steps of the histology process to ensure compliance with standard operating procedures and cGxPs.
- 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 Quality system as denoted by management.
- B.S. in Biology or related science or equivalent work experience
- Technical Certification (HT, HTL, QIHC, or related) preferred/eligible
- 4-6 years Histology Laboratory experience
- 1-3 years in histochemistry (Special Stains)
- 1year immunohistochemistry experience preferred
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status
Responsibilities:
- Proficiently performs Histology testing for QC product release test samples, Clinical (complaint) cases, donor samples, R&D, and engineering studies.
- 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, special stains (histochemistry), and immunohistochemistry as applicable with skillset and training.
- Analyze stain results for accurate and appropriate staining, and to discern if staining is appropriate or if false results were induced through the histological testing process.
- Acts as the final quality check on product prior to product release, by proficiently performing Histology analysis. This requires the ability to analyze stain results to discern if false results were induced through the histological process or if the findings resulted from the production process.
- 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.
- Peer review of sample preparation steps of the histology process to ensure compliance with standard operating procedures and cGxPs.
- 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 Quality system as denoted by management.
- B.S. in Biology or related science or equivalent work experience
- Technical Certification (HT, HTL, QIHC, or related) preferred/eligible
- 4-6 years Histology Laboratory experience
- 1-3 years in histochemistry (Special Stains)
- 1year immunohistochemistry experience preferre