Scientist II (lab Operation)

Lensa; Irvine (CA); On-site; USD 85,000 - 130,000; Full time

Job summary

Lensa is looking for a Laboratory Scientist to ensure data integrity and compliance in a GMP-regulated setting. Successful candidates will draft critical documents, oversee laboratory instruments, and support investigations. This one-year contract role requires a strong academic background and relevant experience in a regulated environment.

Qualifications

• Minimum 3 years of relevant laboratory experience.
• Strong knowledge of regulatory compliance.
• Excellent communication and pressure handling skills.

Responsibilities

• Maintain data integrity and compliance in laboratory reports.
• Draft technical documents like OOS reports.
• Oversee laboratory instruments to ensure compliance.

Skills

GMP regulated drug development

Knowledge of CMC data types

cGMP, FDA, and EMA regulations

Education

BS in molecular biology, biochemistry, or related field

Job description

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Location: Irvine, CA - ONSITE

Contract: 1 year

Responsibilities

• Perform data and document review to ensure data integrity and compliance of laboratory reports including but not limited to Microbiology and Analytical data, method validation, stability and technical reports.
• Draft technical documents including but not limited to OOS and non-conformance quarterly trend reports, equipment Out of Tolerance investigations, Standard Operating Procedures and Work Instructions.
• Oversee critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules. Initiate equipment change control and assist with coordination of set up and qualification activities for new assets. Assist with OOT investigations in the Asset Management System.
  
  

Skills

• Experienced in GMP regulated drug development environment.
• Knowledgeable of typical data, data types and documentation that are produced in CMC during clinical development of pharmaceutical and biological drugs (e.g manufacturing and QC of clinical trial material, stability testing, test method transfer).
• Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents. Familiarity with CDC compliance requirements for Select Agent Toxin program preferred.
  
  

Experience

• Must possess a BS in molecular biology, biochemistry, or related field with at least three years of relevant experience. Knowledge of GMP, ISO, and FDA regulations a plus. Familiar with process and test method validations. Excellent communication skills. Ability to perform under pressure to meet project deadlines.
  
  

Top 5 Skills/requirements This Person Is Required

• Required Skill 1: Strong working knowledge of data types and documentation produced in CMC during clinical development of pharmaceutical and biological drugs (e.g manufacturing and QC of clinical trial material, stability testing, test method transfer).
• Required Skill 2: Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
• Required Skill 3: Experience in GMP regulated drug development environment.
• Required Skill 4: Experience with non-conformance investigations related to analytical testing and equipment out of tolerance results.
• Required Skill 5: Prior experience working in a biologics environment (regulated by CDC).
• BS in molecular biology, biochemistry, or related field with 3+ years of relevant experience.
• Familiarity with CDC regulations around Select Agents and Toxins.
• Background check for the SRA program for working in biologics laboratory
• Work environment: office, analytical, microbiology and biologic laboratories (toxins)
  
  

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details

Name: Ravi Sharma

Email: [e-mail]

Internal Id: 25-29624

If you have questions about this posting, please contact [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

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