Title - Quality Assurance (QA) Specialist
Duration - 10 Months
Location - North Chicago, IL 60064

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(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 7 to 7 years equivalent experience

Carry out job duties independently, including interpreting, explaining, and applying applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies
· Independently plan and conduct internal system audits and external GxP supplier audits
· Maintain the 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 a 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 functional areas 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 responsibilities. Leads 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:
· Bachelor’s degree, preferably in life sciences or engineering
· Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilising 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 satisfactorysubstitute 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 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 38.00/hr.