GMP Laboratory Supervisor, PharmaDx

Description

Schedule: Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PM

Department: PharmaDx - 511

Primary Purpose:

The GMP Laboratory Supervisor is responsible for the day-to-day supervision and oversight of the PharmaDx GMP laboratory operation and personnel performing manufacturing responsibilities. The GMP Laboratory Supervisor assists the PharmaDx leadership team with operational and administrative functions that facilitate excellent patient care, maintain laboratory functions and ensure quality objectives. In addition, the GMP Laboratory Supervisor acts as a PharmaDx Scientist as needed to cover absences and/or increased production demands.

The GMP Laboratory Supervisor is responsible for ensuring the functions of QC performance and data review, GMP operator training and competency assessment, and test methodology performance studies.

This position is not qualified for delegation of laboratory supervisory duties for NY testing areas.

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

GMP Laboratory Supervisor Essential Functions:

Conduct self in compliance with all ARUP Policies and Procedures

Provide effective leadership and direction to workforce members.

Monitor and manage workforce member performance.

Ensure adequate allocation of resources including financial, instrumentation, supply, and personnel.

Monitor and manage internal inventory, manufacturing schedules and communicate impact and solutions to testing delays as needed.

Ensure competency assessments are performed for direct reports performing supervisory functions.

Ensure the orientation, training, and competency of manufacturing personnel prior to independently performing manufacturing activities per ARUP policy and regulatory requirements. Ensure that training needs are identified and addressed to maintain competent workforce.

Ensure that sufficient appropriately qualified manufacturing personnel are recruited and trained to manage the complexity and scope of service provided, and that the competency of all individuals performing manufacturing procedures is regularly reviewed.

Provide clear and timely communication, including bringing problems and non-conformities to the attention of the laboratory management.

Ensure or perform day-to-day supervision of manufacturing performance by manufacturing personnel.

Ensure effective problem resolution and corrective actions.

Monitor manufacturing performance to meet the quality and service standards of the organization.

Ensure or perform Quality Control, Quality Assurance, and Quality Improvement to maintain acceptable level of manufacturing performance.

Ensure actions are taken when test systems deviate from the laboratory’s established performance specification.

May participate in selection of test methodology.

May participate in establishment and/or verification or validation of laboratory test performance.

May participate in ensuring that qualified personnel are employed.

Maintain open and effective communication within the area of responsibility and with all other departments within the organization. Represent the area of responsibility to the rest of the organization. Provide effective leadership and direction to workforce members.

Monitor and evaluate the accomplishment of goals and manages workforce member performance.

Other Essential Functions

Monitors the competency and training of employees in providing diagnostic testing within the scope of the work section.

Hires, holds, and documents formal employee counseling sessions, and terminates as necessary.

Directs the daily workflow assigned to PharmaDx Manufacturing, including work assignments and result review.

Develops and ensures that procedures and methods are performed according to PharmaDx Manufacturing policies and procedures and kept up to date.

Prepares and monitors procedures and schedules for quality control, equipment, instrument and instrument maintenance and enforces compliance.

Consults with the Medical Director(s) regarding technical issues when appropriate.

Ensures all changes within the laboratory are sufficiently validated prior to implementation.

Receives and handles complaints.

May provide technical expertise in the use, calibration, maintenance, and troubleshooting of all laboratory instruments, equipment, reagents, and procedures.

Performs routine and specialized procedures as necessary.

Maintains adequate supply inventories to meet or exceed TAT.

Assists the PharmaDx Director, Technical Operations by providing input for Strategic Planning, annual budget, and Standards of Performance.

Participates in committees, task forces, and improvement teams as defined.

Assists with the complete instrument and/or testing method correlation prior to anticipated implementation.

Other duties as assigned.

Physical Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Continuing Education: Continual assessment of current literature and best practices.

Qualifications

Education

Required

• Bachelor's Degree or better

Preferred

• Master's Degree or better

• PhD or better

Licenses & Certifications

Preferred

• Lean Six Sigma

Experience

Required

• Ph.D. in a relevant technical field Or a Master’s degree in a relevant technical field and two years of experience in a closely related research or clinical lab position Or a Bachelor’s of Science degree and four years of experience in a closely related research or clinical lab position

• Experience analyzing and preparing data

• Proficient with PowerPoint presentations

• Skilled with Microsoft Excel, Microsoft Word, and technical writing

• Demonstrates knowledge of applicable regulations and guidelines

• One year of experience in development, optimization, and/or validation of assays under design control and/or Good Manufacturing Practices

• One year of demonstrated experience designing and interpreting spreadsheets and using word processing software in a research, IVD, pharmaceutical, and/or medical device manufacturing environment

Preferred

• Experience demonstrating increasing levels of responsibility

• Certified Lean Six Sigma Green Belt

• Project management experience

• Proficient with statistical analysis

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.