QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

　　Responsibilities:

　　Supporting the product complaint system; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.

　　Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.

　　 Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.

　　Follow-up on corrective actions derived from investigations through completion.

　　On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.

　　Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.

　　Reviewing and acknowledging information contained in product complaint records

　　Determining if additional information is required to assign appropriate investigation requirements

　　Determining if return samples are required and following its status

　　Reviewing and approving assessments supporting the investigation

　　Conducting and leading cross functional team meetings to determine investigation requirements to be assigned based on event

　　Completing historical data analysis and trend evaluation assessments

　　Voiding records if required

　　Completing customer feedback records if required

　　Own consolidated/trend investigations until closure, if required

　　Qualifications:

　　Bachelor’s Degree in a Science Field

　　5+ years of quality and manufacturing experience in biotech or pharmaceutical industry

　　5 yrs of investigation experience is required

　　Familiarity with basic project management tools

　　Ability to successfully manage workload to timeliness

　　Ability to negotiate a position after taking feedback from multiple sources

　　Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes)

　　Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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