Job description

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 the 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/evaluating 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, and 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 the review/approval of QPRs.
• 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, PowerPoint and other applications.
• Familiarity with Electronic Systems for Batch Records, 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.

Job Type: Contract

Salary: $30.00 - $35.00 per hour

Schedule:

• 8 hour shift

Experience:

• Manufacturing: 5 years (Required)
• Quality control: 3 years (Required)
• Investigations: 3 years (Required)
• Internal audits: 3 years (Required)
• CGMP: 3 years (Required)
• Regulatory reporting: 1 year (Required)

Work Location: On the road

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