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Lead Manufacturing Investigator

2 months ago

Los Angeles, United States Randstad Sourceright Full time

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 Lead Manufacturing Investigator at our Los Angeles, CA site. Here, you will be a vital contributor to our inspiring, bold mission, and have the opportunity to grow within a thriving company.

Summary:

Perform root cause analysis for various deviations in Manufacturing and QC Labs, including OOL, OOS. Responsible for timely documentation of comprehensive Investigations related to environmental monitoring, personnel monitoring, critical systems monitoring, in-process product monitoring, final container testing, and stability testing. Work closely with the corresponding manufacturing, quality assurance, or critical systems personnel to investigate suspect results. Will lead Investigation teams and drive root cause identification with team setting. May be involved with leading teams, encouraging teamwork, problem-solving and making sound (e.g. technical, compliance, and operations) assigned decisions. Analyze bioburden data and prepare presentations for management. Participate and/or drive completion of improvement projects.

Title: Lead Manufacturing Investigator

Location: Glendale, CA - Onsite

Duration: 6 months with potential for extension

Responsibilities:

  • Conduct thorough scientific, defensible Investigations for any OOL, CAPA, or OOS excursion.
  • Conduct and document Investigation In a timely manner to support the on-time closure of on conformances to meet product fulfillment dates.
  • Conduct Investigative sampling pf the manufacturing areas as appropriate. This requires qualification on general sampling techniques (e.g. swab sampling) and basic testing methodologies.
  • Support problem solving sessions through application of the problem solving tools and methods to coordinate and/or lead investigation teams. Will lead routine Investigations and may be required to lead complex investigations.
  • Actively contribute to a team setting at the Los Angeles Manufacturing Facility and potentially with other work teams increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.
  • Work closely with other QA departments and manufacturing operations to conduct investigations, determine appropriate corrective actions, and drive closure of deviations in accordance with cGMP and quality systems.
  • Maintain access to key quality system databases and ensure accuracy of those databases as they pertain to OOL/CAPA/OOS Investigations.
  • Maintain training on general laboratory procedures to enable adequate review of test data, including overall GDP.
  • Assist In developing Investigative sampling plans and/or experiments for root cause analysis of laboratory test techniques or rapid Identification of microbial contamination sources.
  • Lead and/or actively contribute to a team setting with other work teams to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Investigate deviations and write exception documents, when assigned. Ensure personal training requirements are met and that training records are current.
  • Lead or support Deviation Free Initiatives
  • Prepare root cause and/or trend analysis to management during routine operation mechanisms (e.g. Management Review and CAPA Review Board).Must be willing to work flexible hours if necessary

Qualifications:

  • Active Yellow Belt Certification Preferred, Not Required.
  • Understand scientific strategies and be able to invent new processes or new avenues of investigation.
  • Must be able to understand and apply cGMP/GOP, follow CTP/SOPs, and meet EHS requirements; and Deviation investigations.
  • Effective organizational skills and ability to plan and suggest resolutions to technical or resource problems.
  • DMAIC Process (Lean Six Sigma). OOL Criteria's
  • Proficient with lab application software and able to learn new computer systems and programs in a timely manner.
  • Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.
  • Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
  • Must be detail oriented, conscientious and have a high reading comprehension skill.
  • Good understanding or critical manufacturing and facility processes.
  • Effective interpersonal communication and influencing skills. Must have effective verbal and written communication skills. Effective presentation skills a plus.
  • Demonstrate good process, critical system understanding and lead investigations to provide comprehensive investigation write up.
  • Capable of navigating through Quality systems and has working knowledge of event management system.

Education:

  • Bachelor's degree in Science, Engineering or other related technical field.
  • 3+ years of related experience
  • Technical writing experience preferred.

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