Operations and Process Specialist

JOB SUMMARY

The Operations and Process Specialist, under direction of the Manager, National Pharmacy Operations, is responsible for developing, maintaining and auditing Standard Operating Procedures (SOPs), policies, while supporting quality event management, training programs, and continuous improvement initiatives. The specialist collaborates closely with pharmacy operations, leadership and quality teams to monitor regulatory changes, drive process improvements, and uphold patient safety standards. Additional responsibilities include participation in special projects, improvement initiatives and development of education, operational and quality materials within the business line in scope.  The ideal candidate demonstrates strong analytical skills, attention to detail, and a commitment to maintaining the highest standards of quality and compliance across all specialty pharmacy operations.

DUTIES AND RESPONSIBILITIES

•                     Supports pharmacy operations with Quality Event creation, root cause analysis, corrective actions and other operational responsibilities associated with quality events.   

•                     Promotes quality achievement, and identifies process improvements to increase the efficiency, effectiveness, and overall quality throughout the business line.

•                     Draft, revise and maintain Policies, SOPs, WIs related to specialty pharmacy operations and patient services; performs efficacy analysis.

•                     Develop and launch training materials pursuant to Policies, SOPs and Work Instructions; monitor completion and compliance

•                     Support onboarding of new staff, ensuring all mandatory courses are assigned and completed in a timely manner

•                     Assists in ongoing training of staff on SOPs, regulatory updates, and quality protocols

•                     Contribute to department initiatives focused on process and document improvement.

•                     Provides a variety of administrative support services to the Specialty Pharmacy department directors and national directors.

•                     Support pharmacy managers in monitoring changes in pharmacy regulations and ensure timely updates to policies and procedures.

•                     Oversee customer surveys and feedback, collects feedback, shows trends, and coordinates development of preventive action plans as required.

•                     Respond to customer complaints by implementing containment actions, conducting full analysis, and corrective and preventive actions as required.

•                     Support annual audit program performing quality control on site as required. Evaluates audit findings, prepares audit reports, and coordinate action plans with appropriate stakeholders. Conduct spot audits to ensure compliance with regulatory and Bayshore quality expectations.

•                     Support pharmacy managers for program, regulatory, client-based audits

•                     Conduct and manage monitoring procedures such as data gathering, reviews, analysis, and document/case file review, verification, and criteria development. Makes recommendations for improvement as appropriate. Supports performance improvement initiatives as required.

•                     Collaborate with stakeholders to co-develop learning resources and lead onboarding programs.

•                     Works closely with pharmacy operations, leadership, and quality teams to achieve common goals

•                     Support Business Continuity plan creation and annual testing

•                     Assist the clinical pharmacist team in terms of quality and regulatory compliance

•                     Support controlled studies regarding temperature stability of packaging solutions, temperature mapping of controlled areas and general temperature monitoring.

•                     Participates in proactive Health & Safety activities while performing all duties. Is responsible to notify immediate Supervisor of any Health & Safety risks or concerns. Responsible for completing Accident Reports for all direct reports in accordance to Health and Safety protocols.

•                     Maintains confidentiality of client and corporate information and discusses same only with appropriate Bayshore personnel

•                     Complete other tasks as requested

QUALIFICATIONS

Education

•                     Bachelor’s degree preferably in a health or business-related field;

•                     2-5 years of experience in quality assurance, compliance, or operations within a pharmacy or healthcare setting.

•                     Strong knowledge of specialty pharmacy workflows and regulatory bodies

Experience

•                     Working knowledge of organizational development, performance metrics, documentation, and quality assurance, preferably in health care; diverse experience in development of policies and processes, reports, and presentations. Pharmacy experience is an asset.

Other Skills and Abilities

•                     Strong interpersonal skills and ability to work independently and as part of a team; proven ability to build consensus and lead new initiatives; demonstrated ability and competency in Windows software, exceptional organizational skills and ability to meet deadlines; strong commitment to continual learning.  Excellent written and verbal communication skills.