Qc Compliance Associate

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. 

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

QC Compliance Associate

 

DESCRIPTION
BioMarin are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.

The initial focus of the group is to set-up an internal compliance programme encompassing self-inspection, management of executed documents (test records, logbooks and SOP’s) and defining metrics and reporting systems for highlighting issues and an escalation process for same.

In addition the role will include the investigation and co-ordination of LIR’s, CAPA’s, change controls and procedural updates and the overall tracking and reporting of their status. An expertise in Trackwise is essential. 

 

The QC Compliance Specialist will co-ordinate and organise and support the general GMP needs of the QC staff by being an available GMP resource.  This position involves interaction with cross-functional departments and a close relationship with Quality Assurance.

Key factors in the function of this position are flexibility, good organization, having excellent time management, solid tracking and follow up, and being self motivated to make continual progress with minimal supervision and no need for reminders.

 

RESPONSIBILITIES

• Support QC Lab Investigation Reports and Deviations.

• Report on the timeliness of compliance to set timelines on LIR’s, Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise

• Support the internal Compliance Programme within the QC department.

• Self-Inspection Programme

• Management of GMP Records

• Tracking and Reporting Systems

• Full understanding of basic cGMP expectations; set a good example in observance of cGMP policies. 

• Interact with the QC staff regularly to answer questions related to GMPs and help champion a compliant work environment with a Continuous Improvement Focus

• Lead Inspection Readiness efforts for QC

• Lead and Participate in Self-inspections and Compliance walk-throughs of QC.

• Managing Change Requests (CRs)

• Work with QC staff and QA Change Control to contribute to comprehensive implementation plans for CRs

• Comply with cGMP Documentation & Operations

• Compliance with safety guidelines

 

SCOPE

The QC Compliance Specialist works within QC to ensure that the QC department has a robust compliance programme with a well-defined tracking and reporting process to ensure GMP compliance and audit readiness.

 

EDUCATION
• BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 4+ years related to pharmaceutical manufacturing. 

 

EXPERIENCE
• 5+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
• Experience leading and implementing projects
• Demonstrated ability to influence peers and teams with no direct reporting lines.
• Ability to speak, present data, and defend approaches in front of a variety of audiences.
• Organizational skills to contribute to department and cross-functional projects
• Familiarity with FDA & European GMP’s and regulatory requirements, guidelines, and recommendations. 
• Strong proficiency with Trackwise
• Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred.  
• Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.  Experience and proficiency with other applications.