AMVETS Jobs

Inspections

Primary host for internal, customer and regulatory inspections. Liaison for federal and state agencies. Responsible for hosting all inspections. Provide updates and inspection details to senior management. Develop plans and actions for any noted violations and deficiencies. Ensure effectiveness checks for all corrective actions are completed. Oversee the Quality Team

Assign duties to quality team to ensure compliance with procedures and regulations. Ensure quality team supports site operations as required. Ensure all quality processes are followed according to policies and procedures and timelines are respected. Current Good Manufacturing Practice (cGMP) Regulations

Ensure Adherence to cGMP regulations. Ensure policies and procedures align to Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and cGMP regulations. Designated representative for state board of pharmacy licensing. Review and approval of Standard Operating Procedures (SoPs). Controlled Substances

Ensure company policies and procedures adhere to all applicable controlled substances regulations. Act as employee Power of attorney for site. Responsible for the review and approval of suspicious orders. Quality Events

Responsible for the approval of deviations, Non Conforming Material Requests (NCMRs), customer complaints, Corrective and Preventive Actions (CAPAs), Supplier Corrective Action Requests (SCARs). Responsible for the approval of customer complaint letters. Establish necessary corrective and preventive actions related to all quality events. Monitor and analyze quality performance metrics and present findings to senior management. Facility Management and Support Support the validation team on equipment, process and facility validations as required. Responsible for ensuring the environmental monitoring and calibration program requirements are met. Assess and approve change controls as they relate to the facility and Medisca US (MUS) Operations. Leadership

Lead, mentor and develop a team of quality professionals, fostering a culture of quality and continuous improvement. Promote a collaborative approach to problem solving across departments. Encourage open mindset for change management while respecting culture of each location. Foster a culture of excellence by planning and delivering high-quality training, coaching, and performance evaluations for the quality and compliance team. Provide clear and constructive feedback to employees, setting and aligning goals and objectives to drive continuous improvement. Oversee the recruitment, hiring, and onboarding process for new team members, ensuring they receive the necessary training and support to succeed in their roles. Quality Projects and Continuous Improvement

Identify areas of improvement in the quality department and implement risk-based approaches to enhance efficiency and compliance. Qualifications:

Bachelors degree in a Science related field. Experience: Seven (7) to ten (10) years experience in a managerial role in Quality Assurance/Control. Knowledge of cGMP, FDA, and International Organization for Standardization (ISO) regulations. required. Knowledge of European Union (EU), Therapeutic Goods Administration (TGA) considered an asset. Detail oriented, ability to apply analytical thinking and problem solving skills. Proven abilities to apply good judgement, ethical practice and decision making skills. Excellent time management and organizational skills. Required Programs/Software: Knowledge of Microsoft Office (Teams, Word, Outlook, Excel, Access, and PowerPoint) required. Experience dealing with quality management software is considered an asset. Knowledge of Syspro and/or MasterControl programs an asset. Excellent communication skills required; fluent English (oral & written).