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The Position

Manager CAP CLIA Laboratory Operations Tucson AZ

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.

The Opportunity:

Responsible for the daytoday supervision and oversight of the highcomplexity testing laboratory operation and personnel. The duties involve training and assessing the competencies of personnel validating new assays instruments and technology and creating and revising operating procedures. Works closely with the CAP/CLIA laboratory medical director CDx Biosample Management (BSM) inhouse pathologists clinical sciences management (CSM) Assay Development team Companion Diagnostics team and other divisions of Ventana/ ensuring quality control and quality assurance and compliance with CAP CLIA state and federal regulations; Assists in creating department budget managing finances and interacting with clients.

Key Roles & Responsibilities:

• Manages a clinical trial testing laboratory specializing in IHC and ISH tissue staining ensuring highquality and timely patient results for pharmaceutical clients.

• Oversees assay validation prior to implementation and continuously monitors quality control and quality assurance in compliance with regulatory standards.

• Shares responsibility with the Senior Supervisor of CDx Biosample Management for sample accessioning handling protocols and inventory management.

• Supervises and supports laboratory staff through performance reviews realtime feedback corrective actions and ongoing professional development. Ensures all certifications and competencies remain current.

• Leads laboratory participation in proficiency testing programs to maintain the accuracy and reliability of patient testing results.

• Troubleshoots technical issues related to tissue staining instrumentation and reagent performance; ensures regular maintenance and qualification of lab equipment and facilities.

• Serves on the safety committee to maintain compliance with CAP CLIA Roche and other regulatory standards.

• Represents the laboratory during internal and external audits and inspections including those conducted by CAP CLIA FDA and clients.

• Supports the CAP Laboratory Medical Director in assessing lab capacity and workflow presenting operational needs to senior leadership and responding to client inquiries. Also participates in scientific symposia and crossfunctional Roche projects to stay current with evolving technologies and regulatory requirements.

Who You Are:

• Bachelors degree in a chemical physical biological or clinical laboratory science or medical technology with at least one year experience with high complexity testing OR

• Associate degree in a laboratory science or medical technology program with at least two years of experience with high complexity testing.

• 10 years of related experience with high complexity testing CAP/CLIA laboratory operations and general histology.

• Current Certification by ASCPs Board of Certification as a Histotechnician (HT) or Histotechnologist (HTL) required.

Preferred Qualifications:

• ASCP Board Certification in Immunohistochemistry.

• 5 years of histology lab experience including 2 years in a supervisory or managerial role.

• Background in clinical anatomic pathology; familiarity with digital and molecular pathology is a plus.

• Knowledge of CAP and CLIA regulations for Anatomic Pathology.

• Proficient in clinical histological techniques including validation and troubleshooting.

• Strong team management skills; experienced in crossfunctional collaboration.

• Excellent written and verbal communication skills.

Relocation benefits are available for this job posting

The expected salary range for this position based on the primary location of Tucson AZ is between $109800 and $203800. Actual pay will be determined based on experience qualifications geographic location and other jobrelated factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.