Global Product Surveillance Quality Associate ââ
Global Product Surveillance Quality Associate ââ
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Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- This section focuses on the main purpose of the job in one to four sentences.
- This position is responsible for complaint handling will triage incoming complaints for the assigned team and will process all levels of complaints without supervision.
- This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
- The incumbent will perform other duties assigned.
- Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk. Collect necessary complaint information for investigations.
- Determine reportability of a complaint.
- Respond to customer complaints (written or verbal) and write technical investigation response letters.
- Participate in continuous improvement activities and projects (ie: CAPA Product Improvement Teams). May lead projects as assigned by management.
- May have technical approver responsibilities.
- Manage workflow; identify and escalate issues.
- Participate in mentoring and training of the Product Surveillance team. Ability to perform all duties required of previous levels.
Requirements:
- Bachelors degree required. 25 years relevant work experience in cGMP related industry or in a clinical setting.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFRand 211).
- Understanding of the products intended use and manufacturing process of assigned products.
- Strong technical writing skills able to review complaint investigations and write customer response letters.
- Readily accepting of assignments to new/ different products.
- Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures. Excellent written/verbal communication and organizational skills.
- Ability to make independent decisions with minimum oversight.
- Strong problem solving and analytical skills.
- Knowledge and application of computer systems for word processing reporting data analysis and complaint management.
Employment Type
Full Time
