Sr. QA Auditor in Durham, NC at Apex Life Sciences

Date Posted: 6/13/2018

Job Snapshot

Job Description


PURPOSE: 

  • Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures.
  • Prepare and distribute reports of findings to supervisor, operations staff, management, and customers.
  • Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
  • Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. 

RESPONSIBILITIES:

  • Plan, schedule, conduct, report and close audit activities in any of the countries involved with contracts.
  • Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, SOPs and project specific guidelines/instructions. 
  • Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers. 
  • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures. 
  • Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans. 
  • Prepare and review and approve corrective action plans 
  • Present educational programs and provide guidance to operational staff on compliance procedures. 
  • Conduct quality assurance consultancy activities and projects for clients within budget and established timelines. 
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. 
  • Host customer audits, 
  • Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed. 
  • Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections. 
  • May perform GLP Archivist duties where needed. 
  • Assist in training of new Quality Assurance staff. 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of word-processing, spreadsheet, and database applications. 
  • Extensive knowledge of pharmaceutical research and development processes and regulatory environments. 
  • Knowledge of quality assurance processes and procedures. 
  • Strong interpersonal skills. 
  • Excellent problem solving, risk analysis and negotiation skills. 
  • Strong training capabilities. 
  • Effective organization, communication, and team orientation skills. 
  • Ability to initiate assigned tasks and to work independently. 
  • Ability to manage multiple projects. 
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

  • Bachelor’s/primary degree 
  • 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GXP experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience 

PHYSICAL REQUIREMENTS:

  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time 
  • Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech 
  • Travel required, may include international travel.

To apply to this position please send resume to vdagit@apexlifesciences.com  or contact Vickie Dagit, Recruiter, 919-334-0178

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.