Randstad Quality Control in Libertyville, Illinois
salary:$60,000 - $75,000 per year
date posted:Tuesday, August 8, 2017
Position: QC Analyst (PCR)
- 2nd shift, Tues - Sat, 3-11:30PM
The QC Analyst (PCR) provides ddPCR expertise at the GMP Manufacturing facility. This includes technical writing, routine testing, and all other associated activities. The QC Analyst lab responsibilities include, but are not limited to training, routine testing, and method qualification/validations. A potential candidate will possess a strong understanding of PCR techniques and its applications. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. The QC Analyst may also support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The QC Analyst should be able to work effectively within the group, within Quality, and across site.
Perform PCR testing on in-process, release and stability samples.
Conduct thorough investigations to determine root cause of deviations and non-conforming results. Implement appropriate corrective and preventative actions in a timely manner.
Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
Perform other established analytical methods such as protein determination by BCA, SDS-PAGE, TOC, conductivity, pH, testing to support QC operations.
Participate in assay troubleshooting, qualification and validation.
Manage the use and maintenance of scientific equipment and instrumentation, computer systems;
Write and revise documents such as SOPs and technical reports.
Required Education and Experience
Minimum B.A. or B.S. in biochemistry or related scientific field.
Minimum of 2 years of PCR lab experience, preferably ddPCR, with biological products.
Strong knowledge of PCR workflow and applications.