Employment Spot

Job Description

Kelly Scientific Resources is seeking a QA Compliance Specialist II to work with a team to perform operations in the area of the GMP compliance. The Quality Technical Compliance department manages the corporate change control program policy, oversees the change control at the Seattle site, provides oversight of the calibration and maintenance programs for equipment, facilities, systems and computerized systems, and provides oversight of the computerized system validation program. This is a fast-paced high volume production environment with extremely high quality and regulatory standards. Efficiency and accuracy are essential to success in this job. Responsibilities for this position include, but are not limited to the following: ' Prepares GMP change controls for minor/moderate changes; assist with major changes. ' Reviews and/or approves facilities, equipment, and systems work orders. ' Performs or assist compliance monitoring in areas of maintenance and calibration programs. ' Performs review and approval of validations for computerized systems. ' May performs review and approval of validations for equipment, facilities, and systems. ' Contributes to training programs. ' Reviews and analyzes data and documentation. ' Writes documents, standard operating procedures and reports. ' May assist with GMP internal and external audits. ' Represents department in cross-functional teams, projects and GXP-related problem resolution.
Successful candidates should possess the following:
' Bachelor's degree in a scientific discipline or equivalent. ' Typically 2 years related experience in cGMP/FDA regulated industry. ' Proficient in MS Office applications. ' Experience validation and computerized system validation a plus
This is a Direct Hire opportunity that requires employee to work flexible hours. If you are interested please send resume to [Click Here to Email Your Resumé] and place job name in the subject line of your e-mail.
Kelly Scientific Resources is a global scientific staffing organization dedicated to helping scientists of all levels, from entry level to PhDs, advance their careers in industry. We have multiple opportunities available with industry leaders in environmental science and consulting, biotech/pharmaceutical, food science, and manufacturing. Click "Apply Now" to be considered for all positions meeting your qualifications! Learn more athttp://api.careerbuilder.com/v1/joblink?DID=J3G33T77S5PRKVMC4S6&developerkey=WDAW0QF6HDXRBLW245F7

Job Requirements

Bachelor's degree in a scientific discipline or equivalent. 2 years related experience in cGMP/FDA regulated industry. Proficient in MS Office applications.