Quality Assurance Specialist II

Responsibilities:

• Excellent employment opportunity for a Quality Assurance Specialist II, Compliance in the Oceanside, CA area.
• We are seeking a highly motivated individual to join us as a QA Specialist II, Quality Assurance, Compliance.
• In this role you will be responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
• You will report to Senior Manager of Quality Assurance or above.
• Supporting compliance, data integrity, policies and practices to ensure compliance with regulatory requirements and Company procedures and Corporate Policies.
• Conducting or supporting activities for Gap Analysis for various systems.
• Conducting or supporting Internal Audits and Corporate Audits, preparing audit reports and reviewing/ evaluation audit responses.
• Be able to review quality control, validation and other records for regulatory compliance and site procedures.
• Reviewing test results (in-house and by Contract Laboratory) for product release and Stability Study.
• Supporting, reviewing and approving (as applicable) records / activities related to Quality Control, such as Laboratory Investigations, Out-of-Specifications, deviations, non-conformities.
• Reviewing test results and annual reports for Environmental Monitoring (EM) and other trending reports, generated by QC.
• Provide information for Product Quality Reviews and participate in review/approval of PQRs.
• When requested, write, revise and review SOPs, manufacturing documents, methods, specifications, protocols and reports.
• Supporting Management during regulatory agency inspections, Company Global and other audits.
  

Experience:

• 3+ years of experience with BS Degree in the Biological Sciences or related field.
• Working knowledge of Electronic Systems is a plus.
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards.
• Ability to effectively negotiate and build collaboration amongst individuals.
• 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 and able to adjust workload based upon changing priorities.