A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
Responsible for the continual optimal performance of instruments and their operating systems for use in the laboratory.
ESSENTIAL FUNCTIONS
Recordkeeping and validation of new lots of reagent, calibrators and controls. Preparation of in-house controls and calibrators. Perform reagent, QC material, assay, and instrument validations. Install and validate new assays on the screening instruments. Troubleshoot instrument problems that occur too late in the day for a service call and communicate with vendors/service engineers. Ensure that proficiency test surveys are completed correctly and in a timely fashion. Assist with the efficient finishing of the day's workload. Assist with instrument reagent filling. Perform daily, weekly, monthly, and quarterly instrument maintenance. Start calibrations when night shift will be short-staffed. Provide guidance to screening techs relating to workflow, troubleshooting, and data review. Read, know, and adhere to all applicable sections of SAMHSA and non-SAMHSA SOPs. Bring changes in SOP to attention of Alternate R.P. for revision of SOP. Train new personnel and document the training. Maintain appropriate inventory. Maintain screening instruments ensuring good working order. Comply with Certifying Scientist requests for re-analysis, additional documentation, and corrective action. Be proactive in bringing ideas to management's attention to improve productivity, services, quality, policies and procedures, cost savings, and utilization of company resources. Continuously improve skills through in-house training, self-study methods, and other available training resources. Keep work area neat and clean Maintain and protect the confidentiality of all
CRL, CRL
subsidiaries, legal entities and client information. Be able to comply with all applicable federal, state, and local safety and health regulations that would apply to this job. Other duties as assigned.
JOB QUALIFICATIONS
EDUCATION:
A doctoral, master's, or bachelor's degree in medical technology, clinical laboratory, chemical, or biological science.
EXPERIENCE
1 year laboratory instrumentation and operating systems maintenance.
SKILLS & ABILITIES
Strong organizational skills. Good communication skills. Excellent computer skills. Strong analytical ability. Good laboratory technique. Detail oriented; critical judgment and decision making. Must work well under pressure. Able to perform analytical technological functions, i.e. communication, analytical thought, and mechanical ability. Ability to be at work and on time Ability and judgment to interact and communicate appropriately with other employees, clients and management
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be available to enable qualified individuals with disabilities to perform the essential functions. The following physical attributes are required for this position: Sitting for extended lengths of time Close vision requirements due to computer work Repetitive use of hands, fingers, wrists, and elbows for operating a computer and telephone Reaching, including above the shoulder Twisting Bending or stooping Squatting or crouching Kneeling Lifting up to 25 pounds Ability to hear auditory cues
EQUIPMENT
Must operate and maintain automated testing instrumentation.
OTHER:
Must be able to work overtime as necessary to complete workload. Rotation may include Saturday shift. Specimens consist of body fluids and must be regarded as potentially infectious; exposure to caustics, flammables, solvents, carcinogens, and reactive compounds. The employer shall, in its discretion, modify or adjust this position to meet the company's changing needs. This job description is not a contract and may be adjusted as deemed appropriate in the employer's sole discretion. denotes essential job function
An Equal Opportunity Employer Pay Range:
$25.00 - $47.00 Benefits for
Full Time Employees:
Medical, Dental, Vision Life/AD&D Supplemental Life/AD&D Section 125 FSA Plan 401(k) Short and Long-Term Disability Paid Time Off Holidays Tuition Reimbursement
