QA Specialist
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Title - QA Specialist
Duration - 10 MOnths
Location - North Chicago IL
Job Description:
Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation training auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide.
Assures the quality of manufactured products and processes per standard operating processes(SOPS) and GMP (Good Manufacturing Practices). BS degree and/or 7 to 7 years equivalent experience
Carryout job duties independently including interpret explain and apply applicable current regulations guidelines policies and procedures for pharmaceutical products medical devicesand regulated studies
Independently plan and conduct internal system audits and external GxP supplier audits
Maintain approved supplier list global audit schedule and participate in supplier management processes
Gathers internal and external audit metrics and presents to QA management for trend analysis
Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
Provide guidance and training on GxP regulations and guidelines to GxP auditors and functionalareas personnel
Assist GxP QA Management on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers
Develop / maintain and update departmental systems procedures and records pertinent to position responsibilities
Expected to elevate any issues to management as necessary in meeting these goals with cross-functional or broader scope. Resolves project team issues with minimal oversight
This is an experienced level compliance position that reports to the Director GxPCompliance or designee. This individual is expected to identify and resolve problems through effective interpersonal skills. The incumbent will work effectively independently mentor compliance auditors and also be an effective cross-functional team leader.
Qualifications:
experience.
Bachelors degree preferably in life sciences or engineering
Demonstrated strong leadership competencies proficient level of technical capabilities and independence. Proven track record utilizing core & technical competencies
5 years experience in function or related fields such as:Thorough understanding of international GxP regulatory standards (e.g. GMP GLP GCP GDP
GCLP etc.)
Quality Assurance / Regulatory Affairs/Pharmaceutical / Device / Healthcare Industry
Quality Assurance auditing experience (preferred)
Laboratory experience (preferred)
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA)
Experience Level 5-7 Years
Key Skills
- Invoicing
- Information Technology Sales
- IT Support
- Audio Visual
- Database Administration
