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Specialist Quality Complaints

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:    
  • quality experience
  • project management
  • bachelor's degree
Day Day Responsibilities:    
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 this company 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. Doctorate degree
Master’s degree & 3 years of experience directly related to the job
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.

  • 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.
  • Masters 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."

"This posting is for Contingent Worker, not an FTE"

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