QA Specialist - I

Responsibilities:

• Excellent employment opportunity for a Quality Assurance Specialist, Operations in the Oceanside, CA area.
• In this role you will be responsible for a variety of activities to support production and quality of manufactured product.
• You will be located at our Oceanside, CA site and report to Senior Manager of Quality Assurance.
• Support all activities related to product manufacturing and release.
• Ability to achieve and maintain appropriate gowning requirements.
• To provide QA on-the-floor oversight and support to ensure compliance to GMP throughout the area.
• Perform walk-throughs and process observations.
• Perform line clearance and other QA functions in Production area.
• QA review and approval of Master documents (forms, procedures, etc.) related to Production.
• QA review and approval of electronic-executed Production Bach Records and associated records, assigning Production disposition to the produced batch.
• Manage and ensure that deviations, discrepancies, change controls, etc. related to Production are resolved and closed prior to batch release.
• Communicate lot disposition pending issues to Management.
• Escalate issues that may adversely impact timely release of product.
• Support raw materials and components sampling and shipment for testing.
• Oversee Rejected raw materials and finished product, ensure appropriate segregation, disposition and discarding of material/product.
• Support internal audits and inspections related to Production.
• Manage data integrity practices/ requirements in Production as established by company Global Policies, site procedures and regulations.
• Provide information for Product Quality Reviews and participate in review/approval of PQRs.
• Maintain metrics related to batch record review and disposition in support of the Management Review.
• Collaborates with cross-functional departments to ensure timely implementation of quality records.
• The standard work week for this position is Monday-Friday with an eventual shift to include occasional weekend work and/or week schedule as facility transitions to seven-day (4/10) manufacturing schedule.
  

Experience:

• 1+ years of experience with BS Degree in the Biological Sciences or related field.
• 3+ years of experience in the Biological Sciences with High School Diploma.
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards.
• Proficient in MS Word, Excel, Power Point and other applications.
• Familiarity with electronic systems for Batch Record, Quality Management Systems, Veeva and Smartsheet is a plus.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced company environment with minimal direction.