Compliance Specialist

SUMMARY

The Compliance Specialist works with site process owners, CAPA assignees, and QA Reps to effectively manage implementation of corrective and preventive actions in a timely manner. They are responsible for ensuring timelines are met, documentation is complete and accurate, and problems are escalated as needed. Additionally, this position supports audits and audit scheduling.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Ensure regulatory compliance and optimization of quality management system procedures relating to CAPA through development, maintenance, and improvement of documented processes, development, implementation of employee training, and evaluation of competency of CAPA owners and QA Reps.

· Drive CAPA program activities, including working directly with CAPA owners to ensure compliance with regulatory requirements, the robustness of investigations / corrections / corrective and preventive actions, timely responses, and thoroughness of CAPA documentation.

· Identify and report any quality or compliance concerns and take immediate corrective action or escalate as required.

· Report appropriate data and metrics for review by Top Management.

· Provide direction and guidance to personnel across the organization to assist with their learning and effectiveness.

· Support gap analyses associated with changes to domestic and international regulations and standards.

· Support product and material NCR investigations, including evaluation for the need for corrective or preventive action.

· Support internal and external audits of the quality management system as well as audit scheduling.

· Additional duties as assigned.

QUALIFICATIONS

· Energetic, team-oriented, and strong communication skills

· Quality-focused, attentive to detail, and results-oriented

· Ability to identify root cause of a problem and creatively solve problems to gain resolution

· Auditor certification a plus

EDUCATION and/or EXPERIENCE

· Bachelor's or Associate’s degree (or high school/GED 4 years of related work experience)

· Ability to communicate effectively (both written and oral) in English

· Ability to travel within US up to 10%

· Minimum 3 years’ experience in the medical device or pharmaceutical industry

· Minimum 3 years’ experience with CAPA systems, including complaint handling

· Minimum 3 years’ experience applying domestica and international regulations and standards (FDA QMSR, ISO 13485, IVDD/IVDR, etc.)

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

This position works in a typical office setting with a periodic need to work in a laboratory environment. Lab coat, safety glasses, and gloves are required when performing activities within the laboratory environment. Ability to sit for prolonged periods of time, typing, talking, listening, in connection with performing essential functions.

EQUAL OPPORTUNITY EMPLOYER PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

QUALITY COMMITMENT

This position requires compliance with applicable quality management system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

STATEMENT of OTHER DUTIES DISCLAIMER

This job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.