Job Description

Technical Writer II / Investigator
Job Number: 20-08995
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Technical Writer II / Investigator for our client in Durham, NC. 
 
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Leads investigations for Quality deviations and incidents.
  • Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations.
  • May support complex and/or high impact investigations.
  • Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
  • Documents investigation reports and findings in designated Quality systems.
  • Ensures required management and Quality approvals on final investigations while satisfying established due dates.
  • Facilitates corrective and preventive action agreement with stakeholders.
  • Facilitates internal sharing of investigational findings and risk knowledge.
  • Contributes to metrics related to investigation process and CAPA effectiveness.
  • Participates in site deviation/CAPA management forums related to investigation status updates, metrics and escalation items
  • Presents investigations during internal and external audits.
  • Scope & Accountability:
    • Responsible for assigned internal Quality investigations at Biogen manufacturing sites
    • Applies systematic and analytical methods to conduct investigations
    • Documents investigation findings and related actions in alignment with Quality Management System requirements and governing safety regulations
    • Collaborates cross-functionally to ensure robust investigation conclusions, effective communication, and sharing of learnings
 
Qualifications:
  • B.S. degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline.
  • A minimum of 5 years of experience in a lab and operations environment (industrial/plant experience preferred)
 
Required Skills:
  • Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
  • Effective facilitation skills.
  • Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
  • Ability to interpret technical information and documentation used for operations and production activities.
  • Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
  • Experience in performance improvement with basis in Human and Organizational Performance principles.
  • Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
  • Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy.
  • Strong oral and written communication skills.
  • Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | LinkedIn
 
Equal Opportunity Employer:
Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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