Regulatory Science Jobs in Alabama (NOW HIRING)

Job Category: Scientific and Technical Experts

Requisition Number: CLINI001544

• Full-Time
• On-site

Discovery Life Sciences is a trusted provider of genomic, bioanalytic and biospecimen services to hundreds of customers across the United States and around the world. Discovery's expertise focuses on high-throughput sequencing workflow optimization and developing cutting-edge analytical pipelines. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model.

Position Summary:

The Clinical Laboratory Scientist will operate in the Discovery Life Sciences Genomics Laboratory, performing an array of genomics testing including pre-analytical and analytical workflows using various sample types to include but not limited to tissues, oral and nasal swabs, blood, urine and plasma. The Clinical Laboratory Scientist will contribute to Discovery's mission by ensuring consistency of practices based on standard operating procedures and is expected to work in a safe manner adhering to all company, state and federal regulatory requirements.

Must-Have Qualifications (Education, Skills, Experience):

• Bachelor’s degree in medical technology or laboratory science from an accredited institution or equivalent
• Bachelor’s degree in one of the chemical, physical, or biological sciences from an accredited institution and at least 6 months of acceptable supervised experience and/or relevant training; OR Associate’s degree with equivalent experience and/or relevant training
• 1-2 years of clinical laboratory experience
• Knowledge of local, state and federal regulations to include but not limited to GCP/GCLP, 21 CFR Part 11, CLIA/CAP EH&S and HIPAA
• Ability to follow instructions and review laboratory data for quality and consistency
• Ability to execute and prioritize tasks and drive results with a high focus on quality within the expected timeframe
• Strong computer, organizational, and time management skills
• Proficiency with basic lab functions such as pipetting and basic laboratory math (conversions and calculations)

Key Responsibilities:

• Execute job functions using independent judgement with minimal supervision
• Perform pre-analytical and analytical testing procedures in accordance with the laboratory's standard operating procedures to include:
  • Specimen handling and processing
  • Quality Control
  • Preparation and aliquoting of reagents
  • Test analysis to include documentation and data reporting
  • Reporting and maintaining records of all lab tests and procedures
• Maintaining records that demonstrate proficiency testing samples are tested in the same manner as patient samples
• Adhere to the Laboratory's quality control policies and procedures including executing and documenting all:
  • Quality Control activities
  • Instrument and procedural calibrations and verifications
  • Equipment maintenance and preventative maintenance
• Follow the Laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable ranges of performance
• Identify and document problems that may adversely affect test performance, notifying the supervisor or director
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications
• Operation of basic and specialized laboratory equipment
• Review, interpret, and monitor test data as required
• Participate in activities to maintain laboratory operations to include but not limited to:
  • Inventory management
  • Cleaning activities (including execution documentation)
  • Equipment maintenance activities (including execution documentation)
  • Process improvement initiatives
• Execute and record laboratory reagent and equipment qualifications
• Report all concerns of quality and/or safety to Laboratory Management or the Safety Officer
• Communicate effectively, consistently and clearly with Laboratory Management, cross-functional teams/departments and other laboratory staff
• Perform basic assay and/or equipment troubleshooting that adversely impacts test performance, reporting any issues to Laboratory Management
• Can execute all workflow activities in at least 1 of the 5 laboratory workflows
• Ensure compliance with CLIA, CAP, and other relevant regulatory

Compensation and Benefits:

Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay rate offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

Your annual salary is only one part of your total compensation package. Other benefits:

• Competitive salary and benefits package options including medical, dental, vision, life, and disability which start on your first day of employment!
• 401(k) match program which starts on your first day of employment
• Generous vacation and paid time off, paid parental leave, paid family leave, etc.
• Professional development opportunities and reimbursement for relevant certifications.
• Collaborative and inclusive work environment that values diversity
• Team-building activities and social events
• Employee Referral Program and Colleague Recognition Program

Location and work hours:

• Monday – Friday 8am – 5pm local time
• Less than 5% domestic or international travel required for mandatory site meetings and trainings

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.