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** a. 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). b. Required Skill 2: Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents. c. Required Skill 3: Experience in GMP regulated drug development environment. d. Required Skill 4: Experience with non-conformance investigations related to analytical testing and equipment out of tolerance results. e. 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: ravi.sharma@ustechsolutionsinc.com Internal Id: **25-29624**