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Quality Assurance Supervisor - United States  

Company managed [?] Still accepting applications

Posted on : 08 June 2017

Project Description

BASIC SUMMARY:
  • Supervise and provide support in the management of daily work flow operations of Quality Assurance (QA) staff.  
  • Ensure staff assignments are in alignment with regulatory inspection and reporting requirements.  


ESSENTIAL DUTIES AND RESPONSIBILITIES:  
  • Oversee daily operational activities/schedules and ensure QA resources are properly assigned to manage regulatory oversight.  
  • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures.
  • Review, revise and approve (GMP QA) SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
  • Participate in the preparation and review of study and QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained.  
  • Participate in client site visits and regulatory inspections.
  • Participate in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.     
  • Routinely provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of regulations and quality principles.
  • Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures as needed to support departmental workload.
  • May participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
  • Assure the suitability of materials and supplies for compliance with specifications (GMP QA).
  • Review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product (GMP QA).
  • As required, oversee maintenance of group training manual and training records.
  • May assist in development of departmental budget.
  • Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development.
  • Support the policy of equal employment opportunity through affirmative action in personnel actions.
  • Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
  • Perform all other related duties as assigned.



Qualifications
Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
Experience:   Minimum 5 years experience in a Quality Assurance role or a GLP environment including 1 year supervisory experience.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure:  None.


Other:  
  • Knowledge of Microsoft Office applications (e.g. Word, Access, Excel).  
  • Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. 
  • Excellent judgment, decision-making, training/mentoring skills and verbal/written communication skills. 
  • Strong leadership, organizational skills and detail oriented. 
  • Able to prioritize workload and manage multiple tasks. 



Equal Employment Opportunity
Our company  is an Equal Opportunity Employer M/F/Disabled/Vet