Quality Control and Assurance specialist

Quality Control and Assurance Specialist

The Quality Control and Assurance Specialist will establish and maintain quality assurance standards and measures throughout the organization that complies with regulatory requirements and standards.  This position is responsible for working with senior leadership to assure that the company is compliant with all industry standards for quality assurance and computer system validation. 

EDUCATION REQUIREMENTS:

· Master's degree in a relevant discipline required; or equivalent combination of education and experience

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS: 

· Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.

QUALIFICATIONS/EXPERIENCE:

Five (5) years industry related experience, including at least four (4) years’ experience with Good Clinical Practice (GCP) auditing in the pharmaceutical/clinical research industry or equivalent combination of education and experience required. Must have a minimum of three (3) years of quality assurance with evidence of increasing responsibility. Practical knowledge of federal regulations governing human subject research (21 CFR Parts 11) and guidelines for Good Clinical Practice (ICH GCP) required. Must have familiarity and experience with FDA audit preparation and hosting as well as familiarity with standards and processes for electronic system validation. Experience with developing CAPA reports preferred.  Experience with study design and research best practices is required.  Strong communication (written and oral), organization and interpersonal skills and the ability to interact with staff, sponsors, and regulatory agencies needed. Prior experience or knowledge of auditing and inspections related to regulatory compliance preferred. Proficiency with learning management systems (Compliance Wire a plus) as well as with MS Windows, MSWord, MS Excel, MS PowerPoint, and MS Access.

ESSENTIAL DUTIES/RESPONSIBILITIES 

· Create, review, and update SOPs based on operational/technical needs.

· Work with senior leadership and department heads to identify any needs for new SOPs.

· Develop training and evaluation for staff on SOPs.

· Cultivate and disseminate knowledge of quality assurance best practices.

· Conduct investigations of potential data quality and/or data integrity issues (CAPA). 

· Ensures that applicable computerized systems remain in a validated, 21 CFR part 11 compliant status. 

· Assist in the development of change control processes, practices, and guidelines for new and existing technologies.

· Plan annual internal and vendor audit schedules, conduct audits and complete audit reports.

· Lead and prepare all aspects of external audits, providing auditors with all necessary documentation. 

· Identify external audit requirements and mitigate any company risks to compliance.

· Provide support for internal and external audits, corrective actions, responses, and follow-up.

· Assist in and contribute to strategic planning, risk evaluation and management, and business development activities as requested.

· Attendance, punctuality, and safe job performance are essential functions of the job.

RELATED DUTIES/RESPONSIBILITIES:

· Provide Quality support to staff at affiliated subsidiaries as needed/directed.  

· Participate in training of staff on Quality functions as necessary.

· Complete special projects and other duties as assigned.

· Attend seminars and training to stay abreast of quality management regulations and industry trends.

Other duties as required and assigned by the Vice President, Regulatory/QA.  These may, on occasion, be unrelated to the position

TRAVEL REQUIREMENTS:

· Must be able to travel at least 30%; this will include travel between the Hamilton, NJ and New York, NY offices.