RCI-ABBV-00917 Histology Laboratory Analyst / Equipment Validation & Qualification Specialist

Note:

Manager is particularly interested in a candidate with Histology and equipment validation experience in a GxP environment. If no specific histology experience, I would consider a candidate with experience in validating laboratory equipment in a GxP environment.

Role Overview

• We are hiring for Quality and Laboratory roles supporting a regulated histology lab environment.
• These roles require a blend of hands-on lab expertise and quality assurance knowledge, including GMP compliance, validation, and documentation.

Manager's Update

• Strong GMP / GxP experience (Mandatory – No Flexibility)
• Experience in regulated lab environment (Pharma/Biotech)
• Equipment Validation & Qualification
• Documentation & Change Control
• Quality Systems knowledge
• Exposure to CAPA / Deviations / OOS / OOT investigations, Root Cause Analysis, Data Integrity principles
• Bachelor’s Degree (Required) – Biology or related field
• Histology Certification (Preferred)
• PhD / MD candidates not ideal
• Local candidates strongly preferred
• Relocation will work
• Strong hands-on histology expertise
• QA systems investigation experience
• Leadership / mentoring experience
• Balanced lab QA capability
• 10–20 years experience

Preferred Skills (Good to Have)

• Histology automation
• Process improvement experience
• LIMS implementation/integration
• Data integrity risk assessments
• System classification expertise
• Cross-functional QA exposure
• Leadership / team coordination

Seeking skills/experience in:

• GMPs/GXPs,
• Histology automation and process improvements
• Equipment validations/qualifications
• Microscope slide analysis, Digital imaging and analysis
• Leadership skills
• Document updates and change control
• LIMS (Laboratory Information Management System) development and operation

JOB 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 DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:

• 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.

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
• if requirement not met, eligible with extensive experience

Professional Skills

• Critical Thinking
• Decisions Making
• Build Relationships
• Communication
• Customer Orientated

Other Professional Skills: Please write in any other professional skills specific to the job, including technical skills.

• 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: Word, Excel, Powerpoint, Outlook required; Trackwise and (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.

Professional Skills: Specialized skills needed to perform your current role.

• Adaptability: Demonstrates resilience and versatility when pivoting to meet changing business needs
• Build Relationships: Builds authentic partnerships and connects across groups to get things done
• Business Minded: Thoroughly understands our business, and incorporates strong business perspective when making decisions
• Business Partnership: Proactively fosters partnerships within the business to drive win-win solutions; commits to decisions for the best interest of Client
• Change Management: Responds to change with agility and helps others navigate through change
• Communication: Articulates ideas across various audiences, cultures, and situations
• Content Management: Uses design thinking to create, manage, and collaborate with rigor to address customer needs
• Continuous Improvement : Identifies opportunities, measures impact, and executes simple and relevant solutions
• Critical Thinking : Formulates clear, rational and informed solutions and insights that drive better decisions
• Cultural Awareness: Is culturally sensitive and globally minded in conducting business and making decisions
• Customer Oriented:Puts customers (internally and externally) front of mind to drive business results
• Data Driven:Uses data and analytics to formulate stronger solutions and measure impact
• Decision Making:Uses available data to make sound business decisions quickly and in the best interest of Client
• Drive Execution : Focuses on results, balancing efficiency and quality; sets a standard of accountability and action to effectively accomplish goals
• Innovation: Challenges the status quo and presents creative and bold solutions; does not settle for ordinary or typical
• Manages Tension: Effectively connects with others to resolve issues while diffusing conflicts
• Negotiation: Explores alternatives to reach win-win solutions focused on gaining support and acceptance of parties involved
• Networking: Connects with key contacts and builds internal and external networks to expand personal perspective and to drive better business results
• Problem Solving: Draws from all available resources (data, knowledge, experience, etc.) and uses logic to develop solutions to complex or difficult issues
• Project Management:Effectively manages projects using robust plans, stakeholder engagement, and communications for driving timelines
• Risk Management:Forecasts and evaluates risk to make insight-driven decisions; implements measures to mitigate unnecessary risks
• Stakeholder Management:Engages stakeholders to ensure alignment, identifies impacts and develop plans that meets each stakeholder’s needs and are appropriately communicated
• Strategic Planning:Applies knowledge to set priorities and develop plans to achieve a future vision

Leadership Skills: Skills that are expected of all colleagues at Client.

• Excellence Focused:Demonstrates discipline and commitment to turn strategy into reality; drives results by focusing on prioritization and continuous improvement.
• Inquisitive:Shows curiosity, asks probing questions, and challenges the status quo to make strong decisions while managing and driving change. Strength Focus
• Optimistic:Has a positive outlook; aligns with business needs and has a can-do attitude.
• Open and Authentic:Is emotionally intelligent and magnifies diversity of markets, people and perspectives to drive business outcomes.
• Acts as an Owner:Uses resources and makes decisions in the best interest of the company.
• Influencer:Persuades others to follow a path; can negotiate to win.
• Talent Magnet:Invests in people; amplifies strengths to build the best talent; adeptly manages unproductive and destructive behaviors.
• Courageous:Takes calculated risks, accepts limitations, makes difficult decisions and trade-offs between choices.
• Strategic Foresight:Thinks ahead and anticipates changes to capitalize on opportunities while remaining agile and fluid.
• Boundaryless Mindset:Behaves as an enterprise thinker and acts across lines of business and geographies.
• Inspirational:Creates and effectively articulates a vision for the future and moves people to take action and reach new heights.
• Outside-In Perspective:Champions a customer first philosophy; balances external perspectives with internal needs.