Quality Assurance Specialist - 26-00302

Job Title: QA Specialist Duration: 12 Months Location: Oceanside, CA 92056PR: $36/hr - $45/hr on W2 Job DescriptionWe are seeking a highly motivated individual to join us as a Quality Assurance Specialist II. In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. You will be located at our Oceanside, CA site and report into the Sr. Manager of Quality Assurance Operations.The standard work week for this position is M-F, however weekend/night work will be required during manufacturing campaigns to support process operationsKey Responsibilities (include but are not limited to):Perform Quality Assurance related production and production related activities (Batch Record review, Line Clearance, and on the floor support)Provide Quality oversight/approval of Quality Control activities (Method transfer, Certificate of Analysis, nd Stability)Approve shipments and provide oversight during packaging of productEnsure timely assessment and closure of discrepancies, Deviations, CAPAs and Change ControlsEnsure timely assessment and closure of Laboratory InvestigationsEnsure timely assessment and closure of batch and material hold eventsCommunicate lot disposition pending issues to ManagementProvide on-the-floor QA oversight and support to ensure compliance to GMP throughout the areasPerform walk-throughs and process observationsPerform Document Control administrative activities including archival and updating of site training recordsSupport Regulatory Body Inspections of the facilityEnsure products are manufactured in compliance with regulatory and GMP guidelines.Escalate issues that may adversely impact timely release of productIdentify compliance risks and escalate the issues to appropriate levels of management for resolutionGenerate and update procedures and forms as neededPerform additional duties as neededBasic Qualifications:Master’s Degree and ORBachelor’s Degree and 2+ years’ experience in the biological sciences or related field ORAA Degree and 4+ years’ experience in the biological sciences or related field ORHigh School Degree and 5+ years’ experience in the biological sciences or related fieldPreferred Qualifications:Quality Control background in Analytical, Virological, and Microbiological testingWorking knowledge and ability to apply GMPs in conformance to U.S. and EU standardsAbility to effectively negotiate and build collaboration amongst individualsProficient in MS Word, Excel, Power Point and other applications. Experience with Veeva, Smartsheet and LIMS is highly desirableExcellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentComfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities