Quality Assurance Specialist

Lancesoft

Marlborough, MA

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JOB DETAILS

SALARY

$45.36

LOCATION

Marlborough, MA

POSTED

10 days ago

Top 3 “must-have”skills or qualities in a candidate:
o Organization
o Logical reasoning
o Investigation experience

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.

What you will do:
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

Who you are:
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

It would be a plus if you also possess previous experience in:
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.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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