Responsibilities:

• Excellent employment opportunity for a Quality Assurance Specialist III in the Santa Monica, CA area.
• Reporting to the Sr Manager of Global Quality Assurance for Raw Materials and Reagents Center of Excellence, you will assist with managing the activities of the Quality Assurance department and supervise quality assurance efforts to ensure conformance to Company Pharmaceutical quality standards and government regulations.
• The Quality Assurance Specialist III will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Company quality practices and be accountable for managing the QA projects and timelines.
• This role is accountable for Quality Assurance responsibilities related to the disposition of raw materials globally on behalf of Company Pharmaceutical.
• Work closely with and provide quality oversight across functions (Network site QA, Global RM and Regents QC and Tech Excellence, Supply Chain, SQM, Process Development, Regulatory Affairs, Manufacturing) within Company and externally to assure compliance and strong relationships.
• Support strong partnership with network wide site QA groups to ensure global RM and Regents QA operations are continuously improved.
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• RM documentation review and ensure resolution of issues to release raw materials.
• Review and approval of raw material OOS, Deviations and CAPAs.
• Disposition of raw materials lot
• Review and approval of Change Controls and ensure proper maintenance and approval of cGMP documents.
• Ensure change controls are initiated, evaluated and implemented appropriately for all regulated changes.
• Support quality walk through of QC lab
• Support regulatory inspections, internal audits, and external audits from partners.
• Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.
• May conduct or serve as a lead/coordinator of investigations and corrective/preventative actions.
• Review and approval of technical (analytical) protocols and reports as appropriate.
• Reviews and approves analytical validation efforts, experienced in method validation and method transfer guidelines per ICH and USP.
• Serves as QA project lead, leads complex quality investigations/deviations, and independently authors or approves concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).
• Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.
• Support Quality Management Review activities and oversee trending of key quality, raw material and GMP metrics
• Provide QA consultations to support QC on the floor process.
• Up to 10% domestic travel

Experience:

• 7 years of experience in a GMP environment with BS Degree in the Biological Sciences or related field
• 5 years of experience in a GMP environment with MS Degree in the Biological Sciences or related field
• In-depth knowledge of and ability to apply GMP in conformance to US, EU, JP and other standards
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Experience with conducting and managing internal and external audits.
• In-depth understanding and application of qualification and validation principles, concepts, practices, and standards.
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills
• Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (CGMP) on a daily basis.
• Advanced technical writing and excel skills are highly desired for creating and presenting reports.
• Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality.
• Ability to effectively generate metrics, and present; data, findings, and improvement initiatives/projects to QA and cross-functional leadership.
• A relevant background in Quality Control or Analytical Development with a role as a supervisor or manager is highly desired