Specialist Quality Complaints

Description:

Remote - any where is US ok

Primary responsibilities include: 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.

FUNCTIONS

Ensures quality of complaint records
Facilitate cross-functional meetings to
Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
Executes against prioritized work plans
Quickly advances 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
Provides guidance and technical advice
Evaluates subject matter specialist assessments
Raises potential Quality issues to Management

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.
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.?