19 days old

Compliance Investigator III Lead

Baxalta U.S., Inc.
Los Angeles, CA 90012
  • Job Code
    R0028903

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Job Description

Summary:

This position oversees and coordinates the operational aspects of ongoing compliance projects and serves as a liaison between project management and planning, project-team, and line management. This position will also manage projects of small to large size scope, in a timely and cost-effective manner. This position is responsible for developing resolutions to meet timelines, goals, and objectives in alignment with the overall department strategy. This position will initiate events as needed, conduct root cause investigations, and close events for Manufacturing under the direction from Compliance Management. Support in assigning proper corrective actions and facilitate implementation.

Essential Duties and Responsibilities:

  • Work with cross-functional teams to ensure that compliance gaps are appropriately addressed
  • Author and manage events
  • Lead projects and problem-solving sessions for high level and complex events, including contamination
  • Represent events and investigations during audits
  • Using investigation/lean tools to develop robust root cause analysis and drive robust actions to ensure elimination of root cause
  • Responsible for driving closure of investigations and events to support lot disposition
  • Develop strategies and drive Batch Right First Time and excursion reduction goals
  • Ensure projects and improvements implemented per established timelines
  • Teach and coach less experienced investigators
  • Expert with selecting and executing troubleshooting/investigation tools
  • Quality system and manufacturing SME
  • Utilize engineering tools to solve problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Mold Flow, SPC, software development)
  • Interacts through program updates and reviews with all levels of management
  • Write and manage events (CAPA investigations, UIs, ICARs, OOXs, containment, and/or corrective actions) under the direction of Compliance Management
  • Other duties as assigned

Qualifications:

  • Ability to drive change and motivate others toward a common vision
  • Ability to lead teams that are not direct reports
  • Effectively compile and interpret data
  • Demonstrated facilitation, problem-solving, and analytical skills
  • Demonstrated sound judgment. Must be confident, resourceful, self-reliant, and self-motivated
  • Knowledge of manufacturing process and equipment Strong knowledge of Quality Systems
  • Strong interpersonal/influencing/negotiating skills
  • Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to senior management
  • Strong project management, organizational, planning, and analytical skills. Must have a working knowledge of project management and investigation/lean tools and possess knowledge of related disciplines
  • Excellent Microsoft Office Suite knowledge (e.g., Excel, PowerPoint, Project, etc.)

Education and/or experience:

  • High School Diploma or GED plus 5+ years of related experience OR Bachelors' degree in science, engineering, or other related technical field and 2+ years of related experience. Some leadership experience preferred
  • PMP (Project Management Professional), Lean/Six Sigma, and/or Lead Investigator Training Certification is preferred. Prefer experience with TQM methods

Physical Demands:

  • Must be able to lift, push, pull and carry up to 25 lbs
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility

Working Environment:

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body
  • No make-up, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in the manufacturing environment
  • Will work in a cold, wet environment
  • Must be able to work multiple shifts, including weekends
  • Must be able to work overtime as required (only for non-exempt positions)
  • May be required to work in a confined area
  • Some Clean Room and cool/hot storage conditions

This job posting excludes CO applicants.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-02-09 Expires: 2021-03-10
Sponsored by:
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Sponsored by:
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Compliance Investigator III Lead

Baxalta U.S., Inc.
Los Angeles, CA 90012

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