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Description:

REMOTE

Our Client 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 Our Client. In accordance with applicable law, Our Client 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 Our Client, its operations, or its staff."

"SUMMARY

Primary responsibilities include: Supporting the product complaint management system at Our Client by conducting complaint investigations. Processing all complaint records from end-to-end adhering with Our Client Complaint policies and procedures, while assuring compliance to federal regulations.

FUNCTIONS
1. Candidate will be responsible for; ensuring complaints are accurately entered into the complaints database in a timely manner, complaints are assessed according to SOP's, escalates issues related to nonconformance, manages timely communication and follow-up of critical complaints, generate and distribute customer response letters.

2. Candidate will also be responsible for working with other Our Client departments, contract partners and call centers to resolve discrepancies/deficiencies.

3. 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
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."

Top 3 Must Have Skill Sets:	Quality Mind set Sense of Urgency Complaints experience (Self starter, take initiative mindset/ critical thinking and able to work remotely and stay on task)
Day to Day Responsibilities:	Primary responsibilities include: Supporting the product complaint management system at Our Client by conducting complaint investigations. Processing all complaint records from end-to-end adhering with Our Client Complaint policies and procedures, while assuring compliance to federal regulations.
Employee Value Proposition:	Career, growth, opportunity
Possible Extension:	Yes
Red Flags:	multiply job turn-over
Interview Process:	Virtual interview