Active Vacancy Role Summary: The Compliance Associate will provide guidance, leadership and training to other business unit personnel to meet compliance goals within the department, as per Good Manufacturing Practices (GMP) requirements. This role reports to the business unit leader. The Compliance Associate will be familiar with the different responsibilities required to maintain the facility in a GMP environment at a biomanufacturing CDMO. The person hired will also have knowledge and experience with the facilities and engineering, supply chain and manufacturing systems used in such facilities, including environmental monitoring systems, equipment maintenance management systems, building and equipment automation systems, and tasks and ticketing systems, including an understanding of their structures, limitations and functionalities. Responsibilities:

Ensures compliance to GMP/Good Documentation Practices and departmental procedures of executed documents. Generates and reviews departmental procedures related to compliance. Generates departmental KPI adherence reports. Uses the SAP enterprise resource planning system to create departmental metrics. Supports vendor/supplier management system. Initiates, leads, performs investigations, coordinates activities and completes deviation reports (e.g. incident reports, issue reviews) in a timely manner. Initiates, leads and performs impact assessments for change control. Manages departmental training program, identifies gaps in training and executes required follow-up actions. Manages the Standard Operating Procedure (SOP) periodic review cycle timelines to ensure the timely review of departmental SOPs. This includes coordinating reviews by subject matter experts (SMEs), revising SOPs, and preparing supporting change request (CR) documents. Leads cross-functional personnel to develop documented risk assessments and mitigation strategies for change controls (CRs)and corrective and preventive action (CAPA) plans for facility-related changes/repairs. Monitors progress and deadlines for Facilities department quality related IRs, CRs, and CAPAs, and assembles required documentation to effectively complete quality objectives. Coordinates training activities for departmental staff, including quality management system (QMS) documents, and directing and presenting GMP-related training. This will include scheduling, preparation of materials, instructing/guiding personnel, and reviewing test results, as applicable. Prepares and participates in internal, client and regulatory audits as SME. Identifies potential areas of compliance risk in the facility; assists with the development/implementation of CAPAs. Possesses knowledge of the applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine (e.g. GMP guidelines; Health Canada, U.S. FDA, EMA, ICHQ7, as well as ISO standards) or medical device development. Builds and maintains a trusted and respectful relationship with other department stakeholders. Assists in a timely manner with investigations for out-of-specification incidents. Assists with addressing audit observations (internal, client, regulatory) and ensures timely closure. Identifies and helps resolve departmental compliance issues. Maintains familiarity with current ALCOA principles. Experience with electronic QMS and root cause analysis methodologies. Able to maintain a flexible work schedule, which may include shift work and weekends to support operating schedules, facility requirements, and/or responding to call-in emergency situations. Completes special projects and reports, as needed. Other duties as assigned, including department-wide projects. Performs cross-functional and/or other duties, as assigned or requested. For example, assists other departments with completing issue review reports CAPAs and CRs, as they relate to Facilities’ action items, to help ensure timely closure. Works in compliance of the Occupational Health & Safety Act and its regulations, reporting hazards, deficiencies and contraventions of the Act in a timely manner.

Qualifications:

At minimum, completion of a 3-year college program in engineering (applied science), or any related technical field or equivalent job experience in a biopharmaceutical company or recognized equivalent. 6+ years of practical and related experience and/or 2 years of on-the-job training required. Minimum 5 years of experience in a GMP environment at a bio/pharmaceutical CDMO. Minimum 5 years of experience in a compliance, documentation or technical role in a bio/pharmaceutical GMP environment. Understanding of facility and process equipment. Strong English written and oral communication skills. Requires a flexible work schedule.

Desired Characteristics:

Collaborative approach to working with cross-functional teams, with good multicultural awareness. Demonstrates initiative and the ability to deliver high-quality outcomes. Leads by example by proactively identifying problems and areas for improvement. Personable, with excellent communication skills. Able to read and understand technical documents. Diligent and service-minded. Able to communicate with external parties through email and phone. Excellent organizational skills with an eye for detail. Able to take direction. Enthusiastic and willing to learn.

OmniaBio

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OmniaBio: Compliance Associate (Environmental Monitoring and Manufacturing) 12-month contract