Job Description

Job Title: Quality Assurance (Entry Level) Location: Marlborough, MA Zip Code: 01752 Duration: 6 Months Pay Rate: $45.36/hr. Keyword's: #Marlboroughjobs; #QualityAssurancejobs; Start Date: Immediate Job Description: Summary The Quality Assurance Specialist is responsible for leading a Complaint Handling Unit (CHU) supporting and executing the triage, investigation, and closure of product quality complaints. Additional key responsibility are metrics, follow-up, and analysis for items in the CAPA and nonconformity system, whether or not complaint related. This position reports to the Senior QA Manager and is part of the Quality Assurance team located at Results Way, MBO, MA and will be an on-site role. Responsibilities:

• Lead a Complaint Handling Unit (CHU) supporting and executing the triage, investigation, and closure of product quality complaints. Tasks include coordinating and supporting investigations, running trend reports, performing statistical analysis of trends, tracking major issues and related corrective actions, assisting in final customer reports, and interfacing with customers in various forms of communications.
• Facilitate risk-assessment activities and acts as QA lead for Field Actions involving Aseptic Filling product groups
• Support internal and external audits as Subject Matter Expert from a complaint handling unit perspective
• Provide metrics and oversight of the deviation, CAPA, and complaint systems, including high-level analysis for management review

Qualification:

• Bachelor's degree in Biological Sciences, engineering, or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry) or equivalent work experience
• Multiple years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
• Experience with root cause analysis, nonconformance investigation, and CAPA management

Previous Experience:

• Experience in a regulated environment such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.
• Proficiency with quality management systems (QMS) and tools like Veeva, TrackWise, Salesforce, Magic.

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

Job Tags

Work experience placement, Local area, Immediate start

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