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Specialist Quality Complaints (JP9738)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Specialist Quality Complaints (JP9738)
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 1/28/2022
Note: Remote until COVID-19 restrictions are lifted.

3 Key Consulting is hiring a Specialist Quality Complaints for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • Primary responsibilities include Supporting the product complaint system at Amgen through triage of product complaints and management of complaint processing and closure in adherence with Amgen Complaint policies and procedures, while assuring compliance to federal regulations.

    FUNCTIONS
 
  • Candidate will be responsible for; ensuring complaints are accurately entered into the complaints database in a timely manner, triaging complaints to determine complaint code and investigation level, determining whether the complaint is associated with an adverse event or medical device, documentation of follow-up communication to complainants for additional information or complaint sample returns, re-assigning complaints to the appropriate investigation site, closing complaints per required timeframes and providing responses to the complainant.
  • Candidate will also be responsible for working with other Amgen departments, contract partners and call centers to resolve discrepancies/deficiencies.
  • Additional responsibilities include prioritizing complaints and understanding the importance of accurate data entry of complaints within the required timeframe, notifying appropriate parties upon receipt of complaints, supporting the complaints returns process by determining follow-up required for complaint return samples and documentation of communication attempts, partnering with call centers providing tactical oversight and support, providing written communication to senior management and team members, and performing other duties as assigned by supervisor.

Basic Qualifications:

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 in English and Spanish.
  • Excellent verbal diction and ample vocabulary is necessary as Specialist will interact with patients to obtain additional information on reported events and sample returns.
  • 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.
  • Candidate must possess outstanding attention to detail and organization skills, effective decision-making skills, focus on process improvements, and ability to manage a large number of complex projects simultaneously.

    OTHER PREFERRED QUALIFICATIONS
 
  • 5 years of biopharmaceutical experience responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment. Understanding of biopharmaceutical bulk and drug product manufacturing and distribution processes. General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
  • Master’s degree preferred.
  • The candidate must be self-motivated, able to interface effectively with various levels, have careful attention to details and an understanding that accuracy and precision in all aspects of work are necessary. Candidate must be able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, and customer service skills to operate and deliver results in a matrix managed GMP environment.
  • Candidate must be well-organized, possess excellent oral and written communication skills, focus on process improvements, possess ability to manage a large number of complex projects simultaneously, and have the ability to function in a fast-paced environment. Candidate must possess the ability to evaluate issues, make quality decisions and understand when to escalate, if necessary.


Top Must have Skill Sets:
  • prior quality/complaint experience
  • excellent communication skills
  • good prioritization and decision-making abilities

Day-To-Day Responsibilities:
  • Review triaged complaint records including assigned complaint codes, determine investigation path, assign assessments, and determine if further information is required.
  • Understand basic device operation to determine complaint codes. Coordinate/follow-up with other departments for required information.
  • Ensure fields are populated correctly. Investigate, process, and close records according to procedures. Manage workload to ensure timeframes are met.

Employee Value Proposition:
Career growth and experience

Red Flags:
Prior quality/ complaint experience is highly preferred

Interview Process:
Phone or Web-Ex - available to interview in afternoons M-F.


We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.



 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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