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Compliance Specialist
Ref No.: 19-14520
Location: Swiftwater, Pennsylvania
Sunrise System Inc. is currently looking for Compliance Specialist in Swiftwater, PA with one of our top client.
Job Title: Compliance Specialist
Job Id: 19-14520
Location: Swiftwater, PA 18370
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Duties
  • Authoring and resolution of deviations in order to meet production and product release requirements.
  • Identification and facilitation of interdepartmental process improvements.
  • Utilize root cause analysis techniques during deviation investigational process
  • Work cross functionally, to develop and implement continuous process improvements
  • Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
  • Collaboration with Technical Writers to write, review, revise and prepare manufacturing documents (BPR, SOP, SWI, etc.) in accordance with cGMP and regulatory guidelines.
  • Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure.
  • Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization.
  • Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
  • Will be responsible for performing administrative tasks such as gathering and preparing documentation to support investigations and or change controls/capas.
  • Working knowledge of cGMP's is required.
  • Must have knowledge of continuous improvement techniques and problem solving skills.
  • Previous experience working within a production department of a pharmaceutical company.
  • Technical Writing experience preferred
  • Candidate must be able to work extended and flexible hours (including weekends) when needed.
Education
  • Bachelor degree and 3-5 years' experience. 
Skills and Experience
  • BPR
  • CAPA
    CGMP
  • Change Control
  • Compliance Specialist 
Additional Skills
  • Optimization
  • Problem Solving
  • Process Improvements
  • Root Cause Analysis
  • SOP
  • Writing Experience
  • Administrative Tasks
  • Continuous Process Improvements
  • Corrective and Preventive Action
  • Documentation
  • Excellent Written and Verbal Communication Skills 
Contact
Pooja Sinha
Direct: (732) 272 - 0316 | Email: pooja.s@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com