Specialist QA - Biotech (4647)

Location: Thousand Oaks, CA
Date Posted: 08-23-2018
Job Title:  Specialist QA - Biotech (4647)
Location: Thousand Oaks, Ca.
Type: Contract
Duration: 12 months with likely extension or hire
Business Unit: Corporate Complaints
3Key Consulting Inc. is recruiting for a Specialist QA with GMP and GxP Experience in managing complaints related to biologics, medical devices and solid dose products, for a global, CA-based, bio-pharmaceutical company.
Job Details:
Primary responsibilities include: Supporting 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. Functions: 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. On occasion, depending on the nature and complexity of the complaint, 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. May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners. 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

COMPETENCIES/SKILLS: 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 Be 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.
Top Must Have Skill Sets:
  • General knowledge of GMP and GxP Experience in managing complaints related to biologics, medical devices and solid dose products
  • Strong project management skills
Day to Day Responsibilities:
Perform Corporate oversight activities including: Auditing of product complaints Generating data and metrics Assist in deep dive (root cause analysis) of product complaints
Employee Value Proposition:
High visibility and learning opportunity after products are launched. Impact on how to improve devices
Red Flags:
  • Lack of GMP/GXP experience
  • Lack of investigational skills
Interview Process: Phone interview asap and in-person.
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.
3KC Talent Acquisition Team
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