Process Engineer, Compliance in El Segundo, CA at APEX Systems

Date Posted: 8/16/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Up to 7 year(s)
  • Date Posted:
    8/16/2019

Job Description

Job #:  994769
Seeking a highly motivated individual for the role of Process Engineer, Compliance to work in the Materials Management Department and support corporate manufacturing and quality goals to ensure the supply of product.
This role will be focused on the compliance and documentation activities related to product shipping, component sanitization, and component receiving; closely collaborating with the Quality department.
 
Responsibilities (include but are not limited to):
  • Manage and track deviations, change controls, CAPA’s, and customer complaints within the Materials Management department.
  • Coordinate efforts across multiple departments to gather supporting justification data to determine appropriate corrective and preventative actions.
  • Initiate change control as related to investigations, procedural changes, and other system/equipment upgrades.
  • Support internal/external inspections by completing responses and tracking commitments.
  • In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations/investigations through comprehensive Root Cause Analysis tools.
  • Represents Materials Management operations in change control, CAPA, and deviation meetings.
  • Devises and implements CAPAs to address root cause and ensure effectiveness.
  • Collaborating with technical and operational stakeholders, writes and/or revises SOPs, work instructions, and other operational related documents
  •  Trends key performance metrics
  • Participates in internal audit/inspection
  • Conducts training
  •  Manages specific projects to meet established timelines.
  • Other tasks and duties as assigned by Management.

 
Requirements:
  • Bachelors’ Degree in life sciences with 5 to 7 years of related professional experience; Quality background preferred
  • Experience leading projects is required
  • Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
  • Experience with investigation and root cause analysis tools
  • Skilled at creating and delivering presentations
  • Technical writing
  • Provides training and guidance to others
  • Experience leading cross functional teams
  • Facilitates cross functional and team meetings.
  • Knowledge of ERP systems implementation is desirable
  • Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project is required.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High energy level and a positive outlook coupled with the requisite 'can do' attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
  • Willingness to think outside of the box and adapt best practices to our small, but growing environment
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility

 
For consideration please email most up-to-date resume with contact information to Brittany Waldron @ bwaldron@apexsystems.com 
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EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.