Senior Histology Laboratory Analyst

Position Summary: The Senior Histology Analyst is responsible for proficiently performing and documenting histological testing per standard operating procedures in compliance with cGxP guidelines and regulations. 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 technique (histochemisty), basic and advanced immunohistochemistry, microscopy and image analysis. The Senior Histology Analyst is also responsible for data review and test result reporting/release, protocol development, process improvement studies, and collaborating with crossfunctional collegues to develop new/alternate techniques such as in-situ hybridization, bone histology, and immunofluorescence. Additional responsibilities include: the maintenance, operation and qualification/validation of histology equipment; document revisions and change control; audit support; investigating abberant test results, nonconformances, corrective action/preventative actions; team metrics; training technicians/peers in histological sample handling, histochemical/immunohistochemical technique, digital imaging and analysis; and may be required to cover meetings for and support management.

Key Responsibilities:

* Acts as the final quality check on product prior to product release by proficiently performing Histology analysis. Discretion to fail product, report and investigate the OOS through the Quality Management system.

* A key responsibility includes data review of technical and analytical aspects of testing and making the final decision on product test acceptability.

* Apply an understanding of gross anatomy and study purpose to determine, dissect, and orient representative samples for histology testing and analysis.

* Collaboration with Medical Directors and Scientists in testing and evaluation of Quality control test samples, Donor tissue, Complaints, and R&D study samples.

* Understand and act on departmental and project objectives and metrics.

* Lead process improvement projects and manage project activities as assigned by Management, and in a time sensitive and project oriented fashion. * Mentor/train/develop team members and others.

* Develop an in-depth knowledge of relevant scientific technologies and conduct studies to improve upon current technique and introduce new technique to support the needs of internal customers.

* Draft new and update Standard Operating Procedures (SOPs).

* Develop and transfer new techniques as needed.

* Process mapping, and process/method improvements.

* 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. This requires the ability to analyze test results to discern if stain produced appropriate results or if false results were induced through the histological testing process.

* Preparation of reagents and solutions for fixation and stain techniques. Selection of appropriate materials and instrumentation from qualified suppliers. Operate, maintain,and qualify/validate standard laboratory/histology equipment (microtome, cryostat, tissue processor, embedding units, stainer/coverslipper, balances, incubator, waterbath, microscope, etc.) as required.

* Follow Laboratory Safety Standards, proper Biohazard & Chemical Waste Disposal, and comply with current Good Manufacturing, Good Laboratory and Good Documentation Practices. Develop compliance awareness in team members and support audit activities. Adhere to company work standards and Code of Conduct. Diligently participate in compliance-related activities as denoted by management, and support the overall Quality System.

Qualification & Experience:

* B.S. in Biology or related science required, M.S. or higher preferred*

* Technical Certification (HT, HTL, QIHC, or related) *

* 8-10 years histology laboratory experience, including histochemistry (Special Stains)

* 3-5 years immunohistochemistry experience or other advanced technical expertise

* if requirement not met, eligible with extensive experience

* Histology, Histochemistry (Special Stains) & Immunohistochemistry (IHC) Technique * In-situ Hybridization (ISH) Technique preferred

* Cell Biology and Tissue Structure knowledge

* Laboratory & Chemical safety, and Blood Borne Pathogens training * Computer Skills: Microsoft Word, Excel, Powerpoint, Outlook required; Trackwise and SAP (preferred)

* Organizational Skills; and the ability to organize and prioritize tasks/projects

* 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

* Leadership skills and experience * Investigative and analytical skills; experience in Laboratory Investigation Reporting

* 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 required * Process Improvement experience, e.g. six-sigma, LEAN principles, etc...

* Validation/Qualification and method transfer experience is a plus

* GDP training; and experience in working in a GMP, GCP, or GLP environment. * Familiar with AATB, ISO, FDA, and USP regulations/guidelines, and audits.