AbbVie

Sr Histology Lab Analyst

Employer
AbbVie
Location
Branchburg, NJ, United States
Posted
Nov 12, 2020
Ref
204914
Required Education
Bachelors Degree
Position Type
Full time
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 protocol development, process improvement studies, and collaborating with crossfunctional colleagues 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, non-conformances, and corrective action/preventative actions; training technicians/peers in histological sample handling, histochemical/immunohistochemical technique, imaging and analysis; and may be required to cover meetings for and support management.

  • Acts as the final quality check on product prior to product release by proficiently performing Histology testing and analysis. A key responsibility includes data review of technical and analytical aspects of testing and making the final decision on product test acceptability. The Sr. Analyst has the discretion to fail product, report and investigate the OOS through the Quality Management system. 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.
  • 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.
  • Understand and act on departmental and project objectives; 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.
  • 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 false results were induced through the production process, or through the histological testing process.


Qualifications

Education and 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


Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• 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.

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.