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CAPA/GMP Documentation Specialist

  • Ref: 292171
  • Type: Contract
  • Location: Parsippany, NJ
  • Industry: Pharmaceuticals
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

HumanEdge has partnered with a Pharmaceutical Industry client to hire a Technical Writer for a long term contract opportunity.  

The Technical Writer - Investigations ensures quality assurance and regulatory compliance throughout the investigation, deviation, and CAPA Management process while adhering to applicable regulatory statute and standards. 

 

 

Job Duties

Role Responsibilities: 

  • To promote the safety, identity, strength, purity, and quality of the products while supporting the overall company business plan. 
  • Supports the Business Unit by providing necessary data, writing reports, and conducting research on various topics. 
  • Stays updated on best practices and quality trends and regulatory requirements.
  • Writes clear, concise and thorough investigations for quality events using quality risk management principles. 
  • Writes clear, concise and thorough investigations for product complaints. 
  • Reviews and approves Out of Specification reports. 
  • Perform RCA using industry standards, such as FMEA, 5Whys, Fishbone diagram. Identify CAPA to remediate and reduce identified risks. 
  • Work with cross functional teams to perform RCA, identify failure modes and propose appropriate CAPA. 
  • Perform Risk Assessments to assess impact to product quality safety and efficacy. 
  • Manages CAPA and CAPA effectiveness processes. 
  • Works with cross functional groups to verify CAPA implementation, effectiveness and timeliness. 
  • Tracks and trends quality event and complaint metrics. 
  • Proactively identifies possible quality events and initiate steps to prevent identified events. Identifies opportunities for continuous improvement. 
  • Acts as a QA liaison in Client and internal project meetings. 
  • Reviews and approves laboratory deviations and investigations. 
  • Assists with development/writing of quality SOPs, documents and/or reports as needed. 
  • Provides support during regulatory inspections and client audits. 
  • Summarizes and trends quality events within Annual Product Reviews
  • Other duties as assigned.

 

Experience & Skills Required

Required Skills: 

  • Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide process improvements
  • Of particular importance understands quality systems
  • Possesses some knowledge of project management tools and has some experience leading cross functional teams
  • Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information
  • Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
  • Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals
  • Ability to prioritize and respond to changing business demands
  • Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions
  • Critically evaluates quality systems to propose best practices
  • Strong problem solving skills and analytical assessment for continuous improvement
  • Able to critically think, assess problems and collaborate to come to an appropriate resolution
  • Proactive and driver of continuous improvement operations. 
  • Applies risk management philosophy to business processes, decisions, and data Innovation
  • Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention
  • Applies risk management philosophy to business processes and decisions