Supply Chain Operations Documentation Specialist - Shanbally, Ringaskiddy, Cork
12 Month Contract - Onsite role
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.
Duties
The Supply Chain Operations (SCO) Documentation Specialist will work in a team environment that is aligned with the Supply Chain Operations team and will be committed to continuous improvement, process understanding, personal development, and demonstration of process techniques that will result in agile and compliant supply chain operations.
The position is responsible for actively supporting the quality and management of Controlled Documents (including Standard Operating Procedures, Work Instructions, Forms, Templates) for Supply Chain Operations. She/He will be responsible for document management for all Shipping/Receiving documentation and support as a documentation specialist.
The candidate will provide hands-on expertise in supporting the documentation of procedures and processes to ensure quality standards are robust and meet global regulatory requirements, company standards and Supply Chain Operations goals.
Main areas of responsibility:
* Controls and manages all documentation activities connected with the receipt and shipment of goods, including all raw materials, intermediates, and finished goods.
* Directs and controls the warehousing of all raw materials, packaging and finished goods in a manner that permits efficient delivery to the appropriate location in support of manufacturing operations.
* Ensures that proper documentation accompanies shipments and release packs.
* Manage the authoring and drafting of SOP’s, ACARDS, Material Specifications and associated forms in conjunction with the various departmental subject matter experts (SME).
* Support document updates and manage timelines for cross functional Projects.
* Act as a SME/Superuser on the Controlled Document System to facilitate the processing and approval of documents.
* Initiate CRs on QMS system (when required) and Manage progress through to closure.
* Coach/Train SCO colleagues in Documentation System and GDP queries.
* Generate Reports/Metrics and analyse trends as required including but not limited to: QMS Daily reports, Doc Tracker Lookaheads, ASI metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics.
* Perform Logbook Review of all closed logbooks, identifying issues and managing timely archiving.
* Perform Area Self Inspections and generate ASI schedule.
* Support and implement continuous improvement initiatives that add value to Supply Chain Operations.
* Support business process excellence implementation within Supply Chain Operations (e.g. 5S, SMED, Leader Standard Work, PPM & Standard work).
* Other duties as assigned.
Skills
* Demonstrated experience working in a cGMP environment.
* Minimum of 2 years documentation administrative experience, including minimum 3-4 years of experience with managing documents (i.e. writing, proofreading).
* A high level of administrative skills – excellent knowledge of all Microsoft office applications.
* One year of experience working with computerized systems in a Supply Chain setting.
* Experience working in the biotech/pharmaceutical industry specifically in the area of Supply chain operations is preferred.
* Strong working knowledge of regulatory regulations and guidelines including FDA, ICH, and EMA. (Both GCP and GLP experience preferred).
* Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred.
* Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
* Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
* Strong process knowledge of supply chain operations.
* Excellent project management skills.
* Proven ability to lead and deliver on multiple initiatives and agile and flexible to work on multiple initiatives.
* Strong continuous improvement focus.
* Strong collaboration skills.
* Experience with regulatory inspections.
Equipment
Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
Education
College or University diploma preferred.
Experience
Experience in a regulated manufacturing environment with excellent knowledge of Supply Chain Operations preferred.
Demonstrated ability to partner with other functional groups to achieve business objectives.
Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to supply chain operations in a pharmaceutical production facility.
Strong communication and interpersonal skills – oral, written and formal presentation skills.
Creative problem solving skills.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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