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Complaint Investigator - quality/CAPA's in Somerville, NJ at Synerfac

Date Posted: 4/5/2019

Job Snapshot

Job Description

Work directly for a growing Central New Jersey area full service contract filler of products primarily used in the personal care industry.

Complaint Investigator - quality/CAPA's

This position is responsible to track, assess, investigate, and resolve complaints, coordinating teams cross functionally to ensure root causes are properly determined and effective CAPAs are created.
You will work closely with Manufacturing, Supply Chain, QC, QA, Product Development, and other product and/or customer facing stakeholders.
This role will ensure that all customer complaints are documented properly, and that feedback is professionally written and submitted within a required schedule. Statistical reviews and trend analysis will additionally be required, as well as verification audits following action implementation.

Key Responsibilities:
•Align with Complaint Coordinator to ensure details of complaints properly captured and items required for the investigation are received as committed
•Work with multidisciplinary and cross-functional teams to ensure the timely completion and closure of complaints
•Ensure effective CAPAs developed to address assessed root causes
•Escalate any new, unknown risk or hazards for further evaluation and decisions
•Generate final complaint investigation conclusion report, compiling input from various stakeholders, ensuring format is highly professional and prepared for direct submittal to customer
•Conduct monthly statistical assessment of complaint, and identify trends and opportunities for improvement with goal of complaint frequency reduction
•Conduct regular follow-up audits to verify effectiveness of CAPAs. Reconvene investigation teams if necessary to address any CAPA gaps

  Job Requirements  

Qualifications and Skills
•Bachelor's degree in chemistry, engineering, related science, or other technical degree
•4-7 years•experience in an FDA or Pharmaceutical regulated Quality Assurance Complaint investigator role
•Working knowledge of medical device regulations, familiarity with ISO13485 and cGMPs
•Ability to manage a team, multiple projects, and meet project deadlines
•An organized, analytical thinker with exceptional attention to detail
•An excellent communicator, both oral and written
•Capable of interpreting data, identifying root causes and generating appropriate CAPAs
•Working knowledge of Word and Excel, with ability to conduct statistical analysis of data

Kevin Stines
Synerfac Technical Staffing
Phone: 732-271-9333
Fax: 732-271-9110