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Quality Assurance Specialist
1 month ago
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Assurance Analyst Receiving and Inspection at our Thousand Oaks, CA site. Here, you will be a vital contributor to our inspiring, bold mission.
Summary:
The QA Receiving & Inspection and Supplier Quality Management is responsible for performing the day-to-day quality operations for QA Receiving & Inspection and Supplier Quality. Perform inspection and disposition of raw materials to support manufacturing demand. Revise documents to streamline the process and maintain compliance.
Initiate and process supplier investigations, perform Supplier Quality metrics and performance monitoring, assist with completion of Supplier notification of change assessments. Execute supplier quality documentation required for supplier qualification.
Title: QA Receiving & Inspection and Supplier Quality Management
Location: Fully onsite Thousand Oaks, CA
Duration: 12 months with chance for extension
Pay: $50-$60/hr. (Very dependent on level and experience)
Responsibilities:
- Responsible for QA Inspection activities associated with visual inspection, assembly, packaging, and label stores management.
- Perform the final review of QA Inspection documentation to support Filled Unlabeled Vial (FUV) and Final Drug Product (FDP) release.
- Identify and assess quality risks in activities and processes according to regulatory agency requirements and guidelines and Takeda quality practices.
- Revise documents to drive continuous improvement including streamlining processes and maintaining GMP compliance.
- Support departmental projects and any quality working teams when required.
- Revise documents to support process improvements, corrective actions, corporate/division compliance, and audit commitments.
- GEMBA participation – on the floor to see the process where events occur and implement robust corrective actions to correct root causes.
- Inspect incoming materials to determine if they meet quality requirements for manufacturing.
- Disposition raw material lots by reviewing the documentation to determine if quality requirements have been met.
- Revise documents to support process improvements, corrective actions, division compliance, and audit commitments.
- Solves material related issues in cooperation with affected departments (e.g., Quality Control, Quality Inspection and Receiving, Manufacturing etc) and responsible supplier(s) via the Supplier Action Report (SAR).
- Execute supply chain documentation and Quality Agreements for supplier qualifications
- Assists with administrative processing of Supplier Notification of Changes
- Performs supplier monitoring by providing performance metrics. Responsible for trending and analyzing data and presentation of Supplier Quality and supplier performance monitoring indicators to all organizational levels.
- Administer and maintain relevant databases, preparing and issuing reports related to receiving/inspection metrics.
- Supports local and global cross-functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality System performance, issue escalation, procurement strategy, and regulatory compliance.
- Assist in external and internal audits by maintaining audit records, extracting data from databases, and creating reports and collecting relevant data.
- May perform other duties as assigned.
Qualifications:
- Knowledge of biotech manufacturing theories and process is a must
- Knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP) is a plus.
- Strong interpersonal skills, written/verbal skills, attention to detail and able to handle multiple tasks/projects concurrently.
- Proficiency in multiple quality systems including exception management, change control, documentation control, product release, supplier quality, etc. with strong decision-making skills utilizing risk management.
- Strong organizational skills and the ability to plan, follow-up, and implement tasks.
- Strong critical thinking and problem-solving skills (DMAIC, Six Sigma, and Lean experience preferred).
- Skilled word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).
- Able to communicate orally and in writing in a clear, concise understandable manner to supervisor and instruct co-employees.
- Bachelor’s degree in science, engineering or another related technical field strongly preferred
- · Minimum of 3 to 5 years of related work experience. Yellow Belt/Green Belt training/certification highly preferred
