Quality Compliant Specialist Jobs

Job Title: Specialist Quality Complaints

Location: Thousand Oaks, CA - 100% Remote

Duration: 12+ Months

Description:

REMOTE (but based out of ATO PST working hours preferred but EST is also OK)

Description:

Primary responsibilities include: Supporting the product complaint system at through the auditing of product complaint records and monitoring of complaint data in adherence with Complaint policies and procedures, while assuring compliance to federal regulations. Data analysis to support complaint team activities as needed. Complete assessments to support complaint activities as needed.

FUNCTIONS

1. Candidate will be responsible for; ensuring complaints are accurately documented in the complaints data base and that the appropriate investigation has been performed, as well as determining whether the complaint is associated with an adverse event or medical device.

2. Candidate will be responsible for working cross functionally with other 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 audit completion of complaints, providing written communication to senior management and team members, and performing other duties as assigned by supervisor.

4. Complete assessments to support complaint activities as needed.

Doctorate degree

OR

Master’s degree & 1 years of experience directly related to the job

OR

Bachelor’s degree & 2 years of experience directly related to the job

OTHER QUALIFICATIONS

• 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.?