Quality Systems Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible. With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees. Your role Reporting to the Quality Systems Manager, CANDIDATES MUST HAVE PRIOR QA EXPERIENCE. PRIOR AUDITING EXPERIENCE HIGHLY PREFERRED. The Quality Systems Specialist is responsible for managing all site inspections including regulatory agency inspections, customer audits and internal self-inspections. This position will support regulatory agency and customer audits by facilitating the “Front Room” activities, writing the audit responses, and tracking all CAPA’s associated with the responses. The role is responsible for managing the site risk assessment process including the identification of risk, evaluation of deficiencies, training and coaching on the risk process. The specialist will be responsible for the oversight of the site change control system which will include facilitation of the change control committee meetings, training, and coaching site employees on the change control process. In addition, the Quality Systems Specialist will support on-going continuous improvement activities of the site’s Pharmaceutical Quality System. DUTIES / RESPONSIBILITIES: Manage regulatory inspections and customer audits Coordinate with area managers to ensure the site is “inspection ready” in each of the areas by monitoring the site during regular site visits Ensure adequate preparation for all regulatory inspections, customer, and internal audits to include documentation and site personnel. Lead the “Front Room” activities for all customer audits.Assist with front room facilitation for regulatory inspections, when required. Involve other site personnel as appropriate depending on the number of inspectors/auditors. Act as SME for the responsible areas as described in the job summary and address inquiries as appropriate. Coordinate the “Back Room” activities during Regulatory Inspections, when required. Compose the formal responses to the audit observations with the assistance of area managers or designees. Ensure follow-up of the corrective action plans initiated after customer audits and regulatory inspections. Document all inspection activities within the TrackWise system according to required timelines. Facilitate the self-inspections management process Perform risk analysis to determine the content and schedule of the annual internal audits. Formalize the audit schedule ensuring that all six systems in the inspection model are considered including quality, production, facilities and equipment, laboratory controls, materials, and packaging/ labeling. Ensure adherence to the audit schedule, audit reporting, classification of deviations, development of responses and the implementation of actions. Provide continuous training for the internal audit team and facilitate professional training when necessary. Administer the site risk assessment process Identify risk and evaluate deficiencies while working with internal departments/business units for remediation. Develop into the Subject Matter Expert (SME) for the site risk assessment process. Provide risk assessment training to site personnel, create, review, and/or approve risk assessments. Ensure remediation activities identified during the risk assessments are progressed and completed. Oversee the site change control system Evaluate the change control system and provide continuous improvement ideas Monitor the system to ensure that all stakeholder approvals, final approvals, actions items and closures progress according to timelines. Facilitate the weekly Change Control Committee meetings. Provide a plan for the upcoming week, ensure all necessary stakeholders are present, and drive for final approval of the change control. Participate in Quality Systems Processes Review and approve all documents associated with the activities of the job description. Write procedures, protocols, reports, risk assessments applicable to the area Assist in procedure, protocol and report writing as necessary. Participate in the tracking and completion of CAPA’s as required Support on-going continuous improvement activities of the site’s Pharmaceutical Quality System. Your profile Bachelor’s Degree in Life Sciences or related field Minimum 3-5 year experience in QA in FDA regulated environment, preferably in a pharmaceutical manufacturing setting. • Communicate clearly and persuasively with people at all levels of the organization as well as customers. • Problem solving ability, strong analytical skills and diplomacy required. • Anticipate and prioritize multiple priorities and ability to switch direction quickly. • Demonstrate customer service and efficiency focus. • Ability to influence others toward desired outcomes to mitigate company risk, ensure employee commitment, and drive desired change. Must be comfortable dealing with and resolving conflict. Strong solutions focus and be comfortable working in an environment which demands strong deliverables along with the ability to identify problems and drive appropriate solutions. • Experience with customer and regulatory audits. Compensation range 73,000.00 - 81,000.00 USD *The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Learn more about us: We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees. Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives. We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential. We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility. Join us and make a difference!