Allergan Senior Histology Laboratory Analyst in Branchburg, New Jersey
Senior Histology Laboratory Analyst
Branchburg, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5842/other-jobs-matching/location-only
Jul 01, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry 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.
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 (paraffin and frozen technique), H&E (Hematoxylin & Eosin) staining, special stains, 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 collegues to develop new/alternate techniques such as in-situ hybridization, bone histology, and immunofluorescence. This individual is also responsible for maintenance, operation, qualification/validation of histology equipment, document revisions and change control, audit support, investigating abberant test results, nonconformances, and corrective action/preventative actions, and training others in histological, histochemical, immunohistochemical technique, imaging and analysis.
Main Areas of Responsibilities
Acts as the final quality check on product prior to product release by proficiently performing Histology testing and analysis.
Responsible for 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.
Applies 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.
Leadership skills/experience, may be required to cover for/support management.
GDP training, experience working in a GMP, GCP, or GLP environment.
Familiar with AATB, ISO, FDA, and USP regulations.
Process Improvement 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
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
Leadership skills and experience.
Additional Requirements and Education:
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
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.