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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical and manufacturing operations, including patient molecular testing, data reporting, and adherence to regulatory guidelines such as cGMP. Proficient in laboratory information systems and technical writing for regulated documents.
Highest-signal resume keywords
Clinical Laboratory TestingMolecular ProceduresCGMP ComplianceLaboratory Information System (LIS)Technical Writing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Molecular BiologyImmunologySerologic TestingQuality Control (QC)Data SummarizationMethod ValidationEquipment CalibrationNAT TestingSample AccessioningRegulatory Guidelines
Soft Skills
Organizational SkillsTeam CollaborationWritten CommunicationVerbal CommunicationClient Interface
Tools & Technologies
Microsoft Office SuiteLaboratory Information System (LIS)MediaLab
Certifications & Qualifications
Bachelor's of Science DegreeCLS (ASCP) Certification
Industry Keywords
CGMPQuality System Essentials (QSE)SOPsClinical LaboratoryResearch Laboratory
About the role
Key responsibilities & impact- Provide hands-on technical support for day-to-day clinical and manufacturing operations
- Perform patient molecular/serologic and manufacturing testing of samples
- Perform and summarize data for review and reporting
- Participate in method validations and validation protocols
- Monitor daily, weekly, and monthly QC of equipment and systems
- Identify instrument or reagent problems and escalate them to the Lead
- Maintain a clean and organized workplace
- Handle PPE, samples, and materials properly; log incoming materials
- Perform high-, mid-complexity, and simple routine tests
- Transfer data accurately, generate electronic reports, document final results, and submit results for review
- Accession clinical samples in the Laboratory Information System (LIS)
- Use LIS to sign off test completion and communicate results readiness to management
- Report incorrect sample submissions and communicate written reports to clients
- Assist with training new employees and perform staff competency assessments
- Adhere to SOPs, Quality System Essentials (QSE), cGMP, and regulatory guidelines
- Perform feasibility studies and assist in developing new assays
- Assist with strategic project testing and summarize data
- Perform annual equipment calibrations
- Use Microsoft tools to summarize quality metric data
- Support Leads by documenting SOP deviations in MediaLab
- Enter deviations and CAPA submissions/updates in MediaLab
- Maintain laboratory organization and appearance
- Place online reagent and maintenance orders using appropriate software systems
Requirements
What you’ll need- Bachelor's of Science Degree in immunology, genetics, molecular biology, or related field required
- CLS (ASCP) or equivalent is a plus
- 4 years of experience in a clinical or research laboratory environment
- Experience in a cGMP environment is desirable
- 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
- Ability to communicate with all levels of staff and management
- Ability to interface with clients
- Proficient in technical writing for inclusion in regulated documents
- Ability to lift and carry objects up to 50 lbs
- Ability to listen and understand instructions
- Ability to apply abstract principles to solve complex conceptual issues
Benefits
Comp & perks- Regular full-time employment
- Occasional travel within the United States