Compliance Specialist Xellia Pharmaceuticals 11 reviews - Raleigh, NC Compliance Specialist Quality POSITION SUMMARY The Compliance Specialist supports the Quality and Compliance systems at the Raleigh facility. The Compliance Specialist is expected to help develop, implement, and maintain systems and procedures designed to maintain a high level of internal and external audit readiness and regulatory compliance. The position is responsible for facilitating the approval of the Annual Product Quality Reviews (APQR) and the development of relevant systems designed to maintain compliance with the various APQR procedures and Regulatory Agency requirements. The Compliance Specialist participates in compliance initiatives based on new regulations, guidance documents and industry standards and applies them to the systems when directed. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Position will be responsible for the following: * Participates in multi-functional project teams as a Quality Compliance representative as directed by the CQA Supervisor or Site Quality Head. * Supports site quality systems including participation in investigation and change control writing, review, and closure, as appropriate. * Actively participates in the review and approval of GMP documents including, but not limited to procedures, validation protocols, engineering documents, critical work orders. * Responsible for compiling and reporting metrics related to site compliance efforts. * Performs the QA review of incoming materials in JDE, as required. * Responsible for compiling, processing and facilitating the APQR. * Responsible for maintaining the Approved Supplier List (ASL), Quality Agreements, and applicable duties associated with corporate supplier management. * Serve as Good Distribution Practices (GDP) responsible person for Xellias Raleigh site with a focus on developing, evaluating and implementing good transportation practices for maintaining product quality and integrity.

• Tracks open records in TrackWise to include Deviations, Environmental Excursions, OOS investigations, CAPAs, and Change Controls to closure. Creates metrics for CAPA effectiveness evaluation. * Assists in ensuring adherence to regulatory requirements and industry guidance through the review of appropriate documentation and internal audit activities as directed by the Compliance Management team. * Responsible for the compliance of the storage and archiving of documents with company policies and Regulatory Agency requirements. * Assists and coordinates compliance initiatives based on new regulations, guidance documents and industry standards as they apply to site Quality Assurance. * Participates in internal and customer or regulatory audits, as required.
• Performs other duties as assigned by CQA Supervisor or Site Quality Head. REQUIREMENTS * Bachelors Degree with 3-5 years GMP Pharmaceutical experience. * Must be able to communicate effectively both verbally and in writing with all levels of employees on all aspects of compliance. * Must have excellent technical writing skills. * Must have experience as a Technical Reviewer. * Computer skills required; experience with TrackWise preferred. * Must have an in depth knowledge of current GMP well as FDA trends and guidelines. * Must possess good communication skills, and developed problem resolution and critical thinking skills. * Must be organized, detailed and have ability to handle multiple tasks at once and redirect focus based on company's needs. Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients quality of life. Together with us, you can help lead the fight against bacterial infections. Read more about Xellia Pharmaceuticals here 17 hours ago - save job - original job Apply On Company Site Other jobs you may like Specialist in Gifts & Entertainment: Anti-Bri... Credit Suisse Raleigh, NC 23 days ago Tax/Compliance Specialist JAGGAER Morrisville, NC 30+ days ago Quality Compliance Specialist Advanced Clinical Raleigh, NC 30+ days ago Tax/Compliance Specialist SciQuest Morrisville, NC 30+ days ago Research Compliance Junior Officer Credit Suisse Raleigh, NC 4 days ago * Compliance Specialist jobs in Raleigh, NC * Jobs at Xellia Pharmaceuticals in Raleigh, NC * Compliance Specialist salaries in Raleigh, NC Xellia Pharmaceuticals 11 reviews Let employers find you Thousands of employers search for candidates on Indeed Upload Your Resume