New

Quality Assurance (QA) Specialist III

Spectraforce Technologies

Aug 13, 2026
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. Supervisory responsibility: (if applicable)N/A[br style="page-break-before: always;" clear="all"]KEY DUTIES AND RESPONSIBILITIES: Describe scope:% of Time or ImportanceActs 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. 50%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.30%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.10%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.5%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.5%job QUALIFICATIONS (MINIMUM REQUIREMENTS):The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job. Education and ExperienceB.S. in Biology or related science required, M.S. or higher preferredTechnical 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 experienceEssential Skills: Refer to the role detail (or similar role details), located on My Allergan Career, to determine the appropriate Leadership and Professional skills. Leadership Skills: These skills evolve as colleagues move through different career stages. It is recommended that you select the up to 3 that are most important for success in the role. For skill definitions please hover over each listed skill.Lead Yourself (typically up through GG10)?[a title="Excellence Focused - Demonstrates discipline and commitment to turn strategy into reality; drives results by focusing on prioritization and continuous improvement" href="#EF"]Excellence Focused?[a title="Inquisitive - Shows curiosity, asks probing questions, and challenges the status quo to make strong decisions while managing and driving change" href="#Inquisitive"]Inquisitive[a name="Optimistic"]?[a title="Optimistic - Has a positive outlook; aligns with business needs and has a can-do attitude" href="#Optimistic"]Optimistic[a name="OA"]?[a title="Open and Authentic - Is emotionally intelligent and magnifies diversity of markets, people and perspectives to drive business outcomes" href="#OA"]Open and AuthenticLead Others (typically GG11 - GG15)?[a title="Act as an Owner - Uses resources and makes decisions in the best interest of the company LEAD OTHERS" href="#AO"]Act as an Owner?[a title="Influencer - Persuades others to follow a path; can negotiate to win" href="#Influencer"]Influencer?[a title="Talent Magnet - Identifies and invests in people; amplifies strengths to build the best talent" href="#TM"]Talent Magnet?[a title="Courageous - Takes calculated risks, accepts limitations, makes difficult decisions and trade-offs between choices" href="#Courageous"]CourageousLead the Business (typically GG16 and above)[a name="BMindset"]?[a title="Boundaryless Mindset - Behaves as an enterprise thinker and acts across lines of business and geographies" href="#BMindset"]Boundaryless Mindset[a name="Inspirational"]?[a title="Inspirational - Creates and effectively articulates a vision for the future and moves people to take action and reach new heights" href="#Inspirational"]Inspirational[a name="OPerspective"]?[a title="Outside-in Perspective - Champions a customer first philosophy; balances external perspectives with internal needs" href="#OPerspective"]Outside-In Perspective[a name="SF"]?[a title="Strategic Foresight - Thinks ahead and anticipates changes to capitalize on opportunities while remaining agile and fluid" href="#SF"]Strategic Foresight Professional Skills: These are role specific skills. It is recommended that you select the 3-5 that are most important for success in the role. For skill definitions please hover over each listed skill.[a name="Adaptability"]?[a title="Adaptability - Demonstrates resilience and versatility when pivoting to meet changing business needs" href="#Adaptability"]Adaptability[a name="BR"]?[a title="Build Relationships - Builds authentic partnerships and connects across groups to get things done" href="#BR"]Build Relationships[a name="BM"]?[a title="Business Minded - Thoroughly understands our business, and incorporates strong business perspective when making decisions" href="#BM"]Business Minded[a name="BP"]?[a title="Business Partnership - Proactively fosters partnerships within the business to drive win-win solutions; commits to decisions for the best interest of Allergan" href="#BP"]Business Partnership[a name="CM"]?[a title="Change Management - Responds to change with agility and helps others navigate through change" href="#CM"]Change Management [a name="Communication"]?[a title="Communication - Articulates ideas across various audiences, cultures, and situations" href="#Communication"]Communication[a name="ContentM"]?[a title="Content Management - Uses design thinking to create, manage, and collaborate with rigor to address customer needs" href="#CM"]Content Management [a name="CI"]?[a title="Continuous Improvement - Identifies opportunities, measures impact, and executes simple and relevant solutions" href="#CI"]Continuous Improvement [a name="CThinking"]?[a title="Critical Thinking - Formulates clear, rational and informed solutions and insights that drive better decisions" href="#CThinking"]Critical Thinking[a name="CT"][a name="CA"]?[a title="Cultural Awareness - Is culturally sensitive and globally minded in conducting business and making decisions" href="#CA"]Cultural Awareness[a name="CO"]?[a title="Customer Oriented - Puts customers (internally and externally) front of mind to drive business results" href="#CO"]Customer Orientated [a name="DD"]?[a title="Data Driven - Uses data and analytics to formulate stronger solutions and measure impact" href="#DD"]Data Driven[a name="DM"]?[a title="Decision Making - Uses available data to make sound business decisions quickly and in the best interest of Allergan" href="#DM"]Decisions Making[a name="DE"]?[a title="Drive Execution - Focuses on results, balancing efficiency and quality; sets a standard of accountability and action to effectively accomplish goals" href="#DE"]Drive Execution [a name="Innovation"]?[a title="Innovation - Challenges the status quo and presents creative and bold solutions; does not settle for ordinary or typical" href="#Innovation"]Innovation[a name="MT"]?[a title="Manages Tension - Effectively connects with others to resolve issues while diffusing conflicts" href="#MT"]Manages Tension[a name="Negotiation"]?[a title="Negotiation - Explores alternatives to reach win-win solutions focused on gaining support and acceptance of parties involved" href="#Negotiation"]Negotiation [a name="Networking"]?[a title="Networking - Connects with key contacts and builds internal and external networks to expand personal perspective and to drive better business results" href="#Networking"]Networking[a name="PS"]?[a title="Problem Solving - Draws from all available resources (data, knowledge, experience, etc.) and uses logic to develop solutions to complex or difficult issues" href="#PS"]Problem Solving[a name="PM"]?[a title="Project Management - Effectively manages projects using robust plans, stakeholder engagement, and communications for driving timelines" href="#PM"]Project Management[a name="RM"]?[a title="Risk Management - Forecasts and evaluates risk to make insight-driven decisions; implements measures to mitigate unnecessary risks" href="#RM"]Risk Management[a name="SM"]?[a title="Stakeholder Management - Engages stakeholders to ensure alignment, identifies impacts and develop plans that meets each stakeholder's needs and are appropriately communicated" href="#SM"]Stakeholder Management[a name="SP"]?[a title="Strategic Planning - Applies knowledge to set priorities and develop plans to achieve a future vision" href="#SP"]Strategic PlanningOther Professional Skills: Please write in any other professional skills specific to the job, including technical skills. Histology, Histochemistry (Special Stains) & Immunohistochemistry (IHC) TechniqueIn-situ Hybridization (ISH) Technique preferredCell Biology and Tissue Structure knowledgeLaboratory & Chemical safety, and Blood Borne Pathogens trainingComputer Skills: Microsoft Word, Excel, Powerpoint, Outlook required; Trackwise and SAP (preferred)Organizational Skills; and the ability to organize and prioritize tasks/projectsTeamwork and Interpersonal Skills. Ability to communicate effectively both verbally and written with all levels of management, internal/external customers, vendors, and those of diverse culturesLeadership skills and experienceInvestigative and analytical skills; experience in Laboratory Investigation ReportingBasic Mechanical skills and lifting up to 20 lbsGood visual skills, manual dexterity and eye-to-hand coordinationAbility to follow SOP's and Work Instructions with attention to detailStrong math skills, aptitude for analysis, and technical writingMicroscopic and Image analysis experience requiredProcess Improvement experience, e.g. six-sigma, LEAN principles, etc...Validation/Qualification and method transfer experience is a plusGDP training; and experience in working in a GMP, GCP, or GLP environment. Familiar with AATB, ISO, FDA, and USP regulations/guidelines, and audits. Enable Skills-Based Hiring No Provide the days of the week and the hours that this position will require: (No Value)