Oceanside, CA
Contract Duration: 6-18 months
Rate: Negotiable
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.