Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Quality Laboratories Analyst II 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 technique (histochemistry), immunohistochemistry, microscopy and image analysis. This individual is also responsible for maintenance, operation, qualification/validation of histology equipment, document revisions, and training technicians and peers in histological sample handling, histochemical/immunohistochemically technique, imaging and analysis. The Histology Analyst may have an opportunity to develop/learn alternate techniques such as advanced immunohistochemistry, in-situ hybridization, electron microscopy, bone histology, method/process validation, Six-Sigma/Lean principles, and document revisions.

• 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.
• When appropriate the Analyst has the discretion to fail product, report and investigate the OOS through the Quality Management system.
• Evaluation of R&D, Clinical, donor samples, and control tissue as requested.
• Collaboration with Medical Directors and Scientists in examining product, donor tissue, clinical samples, and R&D study samples.
• Applying understanding of gross anatomy coupled with the study purpose to dissect representative samples and determine appropriate stains for histology testing and analysis.
• 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.
• Peer review of sample preparation steps of the histology process to ensure compliance with standard operating procedures and cGxPs.
• Develop an in-depth knowledge of relevant scientific technologies to improve upon current technique and support the needs of internal customers.
• Draft new and update Standard Operating Procedures as needed.
• Participate in the training and development of others.
• Diligently participate in compliance-related activities as denoted by management, and support the overall Quality System.
• Adhere to company work standards and Code of Conduct.
• 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 Laboratory and Good Documentation Practices.

Qualifications

• BS in a scientific discipline or related experience
• Technical Certification (HT, HTL, QIHC, or related) preferred
• 6-8 years histology laboratory experience, including histochemistry (Special Stains)
• 1-3 years immunohistochemistry experience
• Histology, Histochemistry (Special Stains) & Immunohistochemistry (IHC) Technique
• 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
• 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
• Process Improvement experience, e.g. six-sigma, LEAN principles, etc…
• GDP training; and experience in working in a GMP, GCP, or GLP environment.
• Familiar with AATB, ISO, FDA, and USP regulations/guidelines, and audits.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and 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.

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