Quality Assurance (Mid Level)

Primary Talent Partners has a new contract opening for a Quality Assurance (Mid Level) with a multinational science and technology company in Duncan, SC. This is a 6-month contract with a potential for extension.

Pay: $50.00 - $55.94/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.


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

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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