Job Title: Specialist Quality Complaints Location: Thousand Oaks, CA 91320/Cambridge, MA Duration: 6 Months
Description ** Will start out remote and then once we're back to the office, can sit out of either Thousand Oaks, or Cambridge, MA **
The team is seeking a Specialist Quality Complaints Owner and member of the Product Complaints and Surveillance team.
The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across the organization.
In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements.
In addition, the team translates information from the market to drive continuous improvement.
The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.
Top 3 Must Have Skill Sets:
Experience working with large volumes of product complaint records,
experience with combination products,
experience with investigation process – RCA (candidate should be able to provide examples that included the key stages in an investigation), and
tangible examples of escalation process and working with priorities
4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to oversee multiple projects simultaneously
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to negotiate a position after taking feedback from multiple sources
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Ensures quality of complaint records
Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
Executes against prioritized work plans
Quickly escalates issues that could impede the ability to close records according to action plans
Maintains compliance with local and global processes
Execution of regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
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