Scientist II (lab Operation)

US Tech Solutions; Irvine (CA); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company as a key player in ensuring data integrity in a GMP regulated environment. This role involves critical responsibilities such as reviewing laboratory reports, drafting essential technical documents, and overseeing compliance of laboratory instruments. If you have a strong background in molecular biology or biochemistry and are passionate about contributing to pharmaceutical and biological drug development, this position offers a unique opportunity to thrive in a dynamic setting. Embrace the chance to make a significant impact in a biologics laboratory while working alongside dedicated professionals committed to excellence.

Qualifications

• BS in molecular biology or biochemistry with 3+ years of relevant experience.
• Knowledge of GMP, ISO, and FDA regulations is a plus.

Responsibilities

• Perform data and document review to ensure data integrity.
• Draft technical documents including OOS and non-conformance reports.
• Oversee laboratory instruments to ensure compliance.

Skills

GMP regulated drug development

Data types and documentation in CMC

cGMP, FDA and EMA GMP regulations

Analytical testing and equipment compliance

Communication skills

Education

BS in molecular biology

BS in biochemistry

Job description

Location: Irvine, CA - ONSITE
Contract: 1 year

Responsibilities:

1. 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.
2. 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.
3. 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:

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).
2. Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
3. Experience in GMP regulated drug development environment.
4. Experience with non-conformance investigations related to analytical testing and equipment out of tolerance results.
5. Prior experience working in a biologics environment (regulated by CDC).

Minimum Requirements:

• 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