The Clinical Laboratory Specialist provides technical, hands-on support for both clinical and manufacturing operations, focusing on patient molecular/serologic and manufacturing sample testing. This role is crucial for maintaining compliance and operational efficiency by performing testing, quality control, data summarization, and participating in method validations.
location: San Marcos, Texas
job type: Contract
work hours: 3 to 11
education: Bachelors
responsibilities:
- Laboratory Testing & Reporting: Perform high-, mid-, and simple complexity routine tests (including patient molecular/serologic and manufacturing testing). Document final results, ensure accurate data transfer and electronic report generation, and submit results for review/release.
- Quality Control & Compliance: Monitor daily, weekly, and monthly QC of equipment and systems. Strictly adhere to SOPs, cGMP, and regulatory guidelines. Utilize software (MediaLab) to document deviations and CAPA submissions.
- Validation & Assay Development: Participate in and assist in summarizing data for method validation protocols. Perform feasibility studies and assist management in the development of new assays.
- Data & System Management: Perform accessioning of clinical samples and effectively use the Laboratory Information System (LIS) for test sign-off. Utilize Microsoft tools to summarize Quality metric data.
- Team Support: Assist with training new employees and perform competency assessments of all staff.
qualifications:
- Education: Bachelor of Science Degree in immunology, genetics, molecular biology, or a related field. CLS (ASCP) or equivalent is a plus.
- Experience: Entry-level position; no previous experience required, but twelve (12) months or less of experience in a clinical or research laboratory is a strong plus.
- Knowledge & Skills: Practical knowledge of immunohematology and molecular procedures, including NAT testing. Proficiency in MS Office Suites and the ability to interface with clients.
- Core Competencies: Strong written and verbal communication skills, including proficiency in technical writing for regulated documents. Excellent organizational skills and a demonstrated ability to promote teamwork and positive morale.
skills: SOP, Corrective and Preventive Actions (CAPA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
