Job Description

Software Guidance & Assistance, Inc., (SGA), is searching for a Laboratory Compliance Specialist for a Contract assignment with one of our premier Pharmaceutical Services clients in Irvine, CA.

Responsibilities: The Lab Technician is based in Irvine, CA and will support R&D by ensuring optimal operation efficiency of the laboratories. Primary area of support is Research and External Scientific Innovation, and includes multi-disciplinary interaction with EH&S, Managed Lab Services, Facilities & Corporate Engineering, and Pharmaceutical Development with emphasis on planning, coordinating and executing logistical lab operations. Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with internal and applicable regulatory requirements. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. Assist in developing/ improving ELISA based assays for biomarker, PK and immunogenicity and analyze study samples. Design experiments and testing schemes, analyze samples, analyze data, write protocols and reports and present results to a cross-functional team. Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, lifting and or moving records and materials weighing up to 25 pounds, vision to monitor and moderate noise levels. Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Shall be able to perform under pressure to meet project deadlines. On site job.

Required Skills: Must demonstrate strong problem solving and analytical skills and be a team player. Must possess a BS in molecular biology, biochemistry, or related field with at least one to two years of relevant experience. Familiar with process and test method validations. Excellent communication skills.

Preferred Skills: Knowledge of GMP, ISO, and FDA regulations and audits a plus.

Company Description

SGA started in 1981 as a Wall Street / Financial Industry focused IT Resource Solutions company. Throughout growth and expansion into more vertical industries across North America, we’ve built internal teams and processes to best match the needs of each client and each vertical. Read on for insight on the Industries We Serve and the Core Competencies currently supported.