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Compliance Specialist

Allergan, Inc.

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Location: Santa Barbara, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: 130718 Required Education: High school or equivalent

Description

Administers and executes CAPA, Nonconforming product, Hold, investigation, and root cause analysis for Allergan Medical (Breast Aesthetics) in Santa Barbara, CA. Functions as subject matter expert in quality assurance practices and utilizes lean tools such DMAIC, 3A, SPC, DOE, 6S and key statistical techniques to conduct investigations and drive quality improvements.  Coordinates quality operation activities in order to support manufacturing runs.  Provides technical quality input to R&D, Manufacturing and QC teams.

This position has full responsibility and accountability to act and make decisions in the respective job duties.  

30%    Administers and executes CAPAs, Nonconformances, Holds, investigations, and root cause analysis.
15%    Determines completeness of documentation for the release of raw materials, components, and final product including batch record review, QC data review, CAPA investigations and Nonconforming Material Reports.
15%    Reviews and assesses the appropriateness of product, process, and document changes of a difficult and complex nature in accordance with Change Control requirements, processes, and edits document changes.  
15%    Reviews and approves CAPA action plans and effectiveness, calibration out of tolerance reports, environmental excursion reports, work requests, complaint investigations, and supplier approval requests.
10%    Assists in the standardization and simplification of quality and manufacturing processes. This will include the use of flow charts and process mapping tools to ensure connectivity of different processes.
10%    Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site and corporate quality goals and priorities.
5%      Participates and supports internal audits and MOH inspections.

This position has a solid line reporting relationship to Director, Quality Operations.

Allergan is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, EMEA, ISO 13485:2003/CMDCAS, Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, EEOC, and ADA.

Incumbent has full authority to make decisions and/or take action that is required to carry out job duties.  Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, 5S housekeeping, cGMP procedures, general business policies, requirements and objectives. Must be willing to take temporary assignments as required.

Requirements

BS in Microbiology, Chemistry, or Related Sciences.  BS in Engineering strongly preferred.
ASQ CQE/CQA, Six Sigma Certified, or Greenbelt is preferred.
Six (6) years of Quality Compliance experience in Quality Assurance, Quality Control or Quality Engineering within the Medical device industry.
Three (3) years of specific Quality Assurance experience required.  Experience in product batch record and/or packaging record review is required.
Knowledge of  risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) tools is required.
Excellent written and verbal communication skills.  
Effectively communicates both up and down the organization and maintains a customer focus.
Excellent planning and prioritization skills with the ability to multi-task and adapt.
Ability to identify, define and resolve problems using a structured methodology.
Previous experience with Ministry of Health (MOH) inspections and responses
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