Quality Assurance

3 days ago

Santa Ana, California, United States Jobs via Dice Full time

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**QA

Location: Santa Ana, CA (Onsite role)

Duration: 6+ Months Contract
Responsibilities:**

  • The Associate II, Quality Assurance works with Manufacturing, Quality Control, and Clinical Development as a Quality Assurance representative.
  • Providing Quality Assurance oversight and support to ensure compliance with Good Manufacturing Practices and Regulatory requirements throughout the site. Including resolving manufacturing and quality operations-related issues.
  • The Associate II, Quality Assurance will provide quality assurance input and oversight in resolving manufacturing and quality operations-related issues.
  • Support the development, review and implementation of the Site s standard operating procedures, quality policies, specifications, and related documentation.
  • Responsible for reviewing and releasing Batch records and products and issuing and review of quality certificates.
  • Support development, review, and approval of quality system documents, protocols, and reports.
  • Lead and support the site's investigation, root cause analysis (RCA), and Corrective / Preventive actions.
  • Perform internal audits and support external audits and regulatory inspections.
  • Lead and support supplier and consultant selection, qualifications, and monitoring, including performing supplier audits and raw material and components auditing and release.
  • Support reviewing and releasing any changes in the manufacturing process, quality control processes, facility equipment/systems, and inspection & test methods.
  • Document control management, including document and logbook issuance, reconciliation and archival.
  • Management of the change control process.
  • Perform real-time quality review and oversight in Manufacturing and Quality Control.
  • Report on time any quality issue to management.

Qualifications & Skills:

  • Bachelor's degree in Biochemistry or related biological field and a minimum of 3 - 5 years of progressive experience in the pharmaceutical, biotechnology, or biologics manufacturing operations,
  • OR 1-2+ years of progressive Quality experience in the pharmaceutical, biotechnology, or biologics manufacturing operations,
  • Working knowledge of and ability to apply Good Manufacturing Practice (GMP) in conformance to US FDA and international regulatory standards and requirements.
  • Experience identifying, writing, evaluating, and closing investigations and CAPAs.
  • Experience with internal and external audits.
  • Highly detail-oriented and excellent interpersonal skills within the collaborative work environment.
  • Comfortable in a fast-paced, small company environment and able to adjust workload based upon changing priorities.
  • Self-motivated and willing to accept responsibilities outside of the initial job description.
  • Excellent technical skills; Microsoft Word, Excel, and Data Analysis.
  • Exceptional time management, problem-solving, and organization skills.
  • Outstanding interpersonal, verbal, and written communication skills in collaborative work.

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