Quality Assurance Specialist (Mid Level)

LanceSoft Inc

Duncan, SC

JOB DETAILS
SALARY
$54.79–$54.79 Per Hour
SKILLS
American Society for Quality (ASQ), Analysis Skills, Biotech and Pharmaceutical, Code of Federal Regulations, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Documentation, Financial Trend Analysis, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Investigative Reports, Manufacturing Engineering, Medical Equipment, Quality Assurance, Quality Management, Research & Development (R&D), Root Cause Analysis, Statistics, Surveillance, Technical Writing, Trend Analysis
LOCATION
Duncan, SC
POSTED
3 days ago
Shift: 1st shift

Job Summary:

What you’ll do:

• Execute the triage, investigation, and closure of product quality complaints.
• Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.
• Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.
• Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.
• Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers

Who you are:
• Bachelor’s degree required; additional training/education preferred through ASQ (or relevant society) and/or Master’s level program
• Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required
• Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
• Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance
• Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints

Must Have:
4 skills needed, Pharma background, quality Management Systems, Technical Writing and complete management experience

About the Company

L

LanceSoft Inc

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/