Planet Pharma · 10 hours ago
Clinical Lab Specialist
San Marcos, TX
Full-time
Onsite
New Grad, Entry Level
$25/hr - $30/hr
0+ years expPlanet Pharma is seeking a Clinical Laboratory Specialist to provide hands-on technical support for clinical and manufacturing operations. The role involves performing molecular/serologic testing, ensuring regulatory compliance, and participating in method validations while maintaining operational efficiency.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Performs duties related to tests, instruments, and reagents. Identifies any potential instrument or reagent problems and escalates to Lead
Maintains the workplace in a clean and organized manner
Maintains proper PPE sample/material handling; logs all incoming materials
Maintains technical competencies; ensures annual competencies are up-to-date; aligns annual CE with competencies
Performs high-/mid-complexity, and simple routine tests
Ensures accurate data transfer and electronic report generation, documents final results, submits results for review
Performs accessioning of clinical samples in the Laboratory Information System (LIS)
Uses LIS effectively to sign-off test completion, communicates to management results are ready for review/release
Reports incorrect sample submissions to management; communicates written reports to clients
Assists with training new employees for routine, moderate, and high-complexity tests; performs competency assessments of all staff
Maintains strict adherence to SOPs, Quality System Essentials (QSE), good manufacturing practices (cGMP), and regulatory guidelines
Performs feasibility studies and assists management in the development of new assays
Assists with strategic project testing; assists in summarizing data
Participates in validation protocols; assists in the summary of validation data
Performs equipment annual calibrations
Utilizes Microsoft tools to summarize daily, weekly, and monthly Quality metric data
Supports Leads document (MediaLab) deviations to SOPs
Utilizes MediaLab software to enter deviations and CAPA submissions/updates
Maintains CE credits consistent with laboratory policy
Qualification
Required
Bachelors of Science Degree in immunology, genetics, molecular biology, or related field and 12 months or less of experience in a clinical or research laboratory environment
At least 16 semester hours of additional graduate-level coursework in chemical, biological, clinical, or medical laboratory science, or medical technology
Practical knowledge of immunohematology and molecular procedures, including NAT testing
Proficient in MS Office Suites
Excellent organizational skills
Ability to work on team projects
Strong written and verbal communication skills
Must be able to communicate with all levels of staff and management and interface with clients
Proficient in technical writing for inclusion in regulated documents
Promotes teamwork and has a positive employee morale
Preferred
CLS (ASCP) or equivalent is a plus
Twelve (12) months or less of experience in a clinical or research laboratory environment is a plus
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase