Specialist QA - Quality Complaints (JP4229)

Location: Thousand Oaks, ca
Date Posted: 05-09-2018
Job Title:  Specialist QA - Quality Complaints (JP4229)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Corporate Complaints
Duration: 1+ years (likely extensions)
 
3Key Consulting Inc. is recruiting for a QA Specialist with 3 - 5 years’ experience in quality complaints within a GMP environment for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
The QA Specialist supports the product complaint system at Amgen through; leading, managing, and/or auditing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.  Job functions include:
 
  • Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
  • Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
  • Follow-up on corrective actions derived from investigations through completion.
  • The specialist may be responsible of conducting and documenting the investigation. Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
  • The specialist may be responsible for communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
 
Top Must-Have Skill Sets:
  • General knowledge of cGMP,
  • Critical thinking.
  • Excellent written and verbal communication skills
 
Day to Day Responsibilities
  • Understands the complaint handling process from initiation to closure.
  • Audit product complaint records and communicate to complaint owners of findings
  • Process and close complaints in a timely manner.
  • Maintain current knowledge of the Regulatory regulations.
  • Serves as an internal review in order to assure regulatory compliance across all product lines.
  • Other duties as assigned
 
Basic Qualifications:
  • Education/Licenses: Doctorate degree or Master’s degree & 3 years of experience directly related to the job or Bachelor’s degree & 5 years of experience directly related to the job
 
Preferred Qualifications:
  • Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
  • Excellent written and verbal communication skills, including facilitation and presentation skills.
  • Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
  • Self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
  • Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.
 
Why This Position Is Open:
Backfill of the worker.
 
Employee Value Proposition:
High visibility with other functional areas.
 
Red Flags:
Lack GMP experience.
 
Interview process:
Phone, and in-person if needed
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.
If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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