Specimen Processor I

Creative Testing Solutions, Inc.; San Marcos (TX); On-site; USD 42,000 - 60,000; Full time

Job summary

The Plasma Testing Laboratory at Creative Testing Solutions, Inc. is seeking a Specimen Processor to handle receipt, accessioning and processing of samples in a high-volume GMP setting, complying with CLIA, FDA and EMA requirements.

Primary duties include quality control, ALCOA documentation, SOP-driven processing, centrifugation, equipment maintenance and safe, accurate handling of donor materials. Overtime and weekend work may be required.

Qualifications

• Education: High School diploma or equivalent required.
• Specimen Processor Level II: minimum 1.5 years of experience.
• Specimen Processor Level III: minimum 3 years of experience.

Responsibilities

• Adhere to quality and safety standards and regulatory requirements.
• Follow ALCOA documentation for records and data integrity.
• Receive and process samples per SOPs; manage cancellations/resubmissions.
• Perform sample centrifugation and suitability checks.
• Maintain equipment logs and keep work areas clean and safe.

Skills

English fluency

Basic math

Computer skills

Effective communication

Attention to detail

Teamwork

Education

High School diploma or equivalent

Job description

Job Description Summary

The Plasma Testing Laboratory Specimen Processor is responsible for performing duties relating to sample receipt, sample accessioning and sample processing in a high-volume setting with a high degree of proficiency, all while providing appropriate documentation following CLIA, FDA, EMA regulatory requirements in a GMP environment.

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

Duties and responsibilities regularly performed by and assigned to Specimen Processor levels I, II, and III:

• Adheres to the laboratory’s quality and safety standards maintaining quality control and assurance, as well as ensuring compliance with all applicable regulatory agencies.
• Follows cGMP for documentation using ALCOA; ensure regulations pertaining to records, reports and data integrity policies are met.
• Receive and process incoming samples in preparation of testing following standard operating procedures (SOPs) as directed by regulatory guidelines. Including processing sample cancellations, sample resubmissions and completing sample reconciliation as dictated by workflow.
• Performs sample centrifugation and sample suitability checks utilizing proper sample handling techniques to ensure validity of test results.
• Performs equipment maintenance according to established schedules and procedures and maintains associated logs to ensure minimal equipment downtime.
• Maintains general cleanliness of department work areas and other laboratory common areas as needed to ensure a clean, safe and professional environment. Accountable for department appearance and organization.
• Disinfects work areas and empty biohazardous waste.
• Works as a member of a team responsible for completing the Plasma Testing Laboratory daily workload.
• Works efficiently to consistently complete heavy workloads while maintaining all quality and safety standards.
• Maintains donor confidence and protects the company by keeping information confidential.
• Performs all other duties, at the discretion of management, as assigned.
• Works periodic over-time, holidays, or weekends as needed.

Additional duties and responsibilities regularly performed by and assigned to Specimen Processor levels II and III:

• Accurately identifies problems that may adversely affect equipment, software, or process performance and assist with troubleshooting. Escalates problems/delays appropriately.
• Maintains technical knowledge of complex automated equipment and manual processes to resolve errors and/or inconsistencies.
• Investigates issues related to sample receipt, cancellation, resubmission, and pending test requests with minimal supervision.
• Performs equipment re-qualifications and/or verifications.
• Performs operations review of source documentation as needed.

Additional duties and responsibilities regularly performed by and assigned to Specimen Processor level IIIs:

• Conducts employee training when applicable while ensuring training qualifications are current and accurate.
• Assists the Supervisor and Lead with managing daily workload and providing overall direction of workflow as needed.
• Reviews equipment service reports and accurately identifies the appropriate re-qualification steps to be performed.
• Serves as a resource for corrections and clarification.
• As appropriately delegated by laboratory leadership:
  • Analyzes, prioritizes and resolves complex equipment problems. Investigates deviations in equipment operations and preventative maintenance.
  • Recommends and implements corrective actions.
  • Assists with competency documentation, records review, and records management.
  • Aids new processes/instrumentation implementation by executing validations.
• Escalates applicable issues to vendors and ensures appropriate follow-up and resolution.
• Provides mentorship and guidance to newer staff.

REQUIRED QUALIFICATIONS

• Education: High School diploma or equivalent required.
• Additional Specimen Processor Level II Qualifications:
  • Must possess at least 1.5 years of Specimen Processor experience.
  • Must possess demonstrated laboratory knowledge and competency in laboratory SOPs and policies to perform job responsibilities defined for the level.
• Additional Specimen Processor Level III Qualifications:
  • Must possess at least 3 years of Specimen Processor experience.
  • Must possess demonstrated advanced laboratory knowledge and competency in laboratory SOPs and policies to perform job responsibilities defined for the level.

SKILLS AND ABILITIES

• Must be able to speak, read and write in English. Writing must be legible and neat.
• Must have basic math and computer skills, effective phone and interpersonal communication skills.
• Must have the ability to apply rational thinking and understanding to carry out detailed but uninvolved written and oral instructions.
• Must pay attention to detail, have strong organizational skills, and the ability to multitask.
• Must possess the ability to deal with problems within the guidelines of standard operating procedures.

PHYSICAL & TRAVEL REQUIREMENTS

• Lab work environment: Exposure to biological fluids with potential exposure to infectious organisms. Exposure to extreme cold ( ≤ -20⁰C), miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Specific vision abilities required by this job include close vision, distance, color, peripheral vision, depth perception and the ability to adjust focus.
• 5+ hours per shift: Sitting, standing, handling. finger dexterity, pinching
• 3- 5 hours per shift: Lifting to 30 pounds
• Up to 3 hours per shift: Walking, climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, pushing/pulling pallets, carrying/move items up to 40 pounds
• Travel:<5%

INTERNAL ADVANCEMENT STATEMENT

In order to be considered for advancement to the next specimen processor level, employees must possess the required qualifications, skills, and abilities as stated in the job description AND regularly demonstrate the qualities and behaviors commensurate with our CTS mission, vision, and values.

The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.

Additional Job Details:

Shift 1

Monday through Friday 8:00am to 4:30pm

Creative Testing Solutions is an equal opportunity employer.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e‑mail [e-mail] let us know the nature of your request. A representative will respond to accommodation requests within five business days. Please note that this email is for medical/disability accommodations only and any other inquiries will not receive a response.

Please see the below information about applicant rights and our commitment to compliance:

Know Your Rights: Workplace Discrimination is Illegal

Pay Transparency Nondiscrimination Provision

E-Verify Participation

Right to Work

All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company’s established guidelines.