QC Release Specialist 2
Responsible for developing, maintaining and coordinating compliant release processes for finished goods manufactured for Hull, ensuring adherence to Company Quality Systems, regulatory, statutory health & safety requirements, and Site Safety Policy. Acts as a subject matter expert in release controls and process of CMO, providing training and support to QC Release Personnel.
Responsibilities
* Apply high standards of occupational health & safety to comply with company policy and procedures.
* Perform all activities in compliance with relevant GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and other applicable quality standards or regulations concerning medicinal products and medical devices.
* Ensure that all Quality Compliance Release external communications meet customer needs and facilitate improvement where necessary.
* Provide Quality Compliance Release support to CMO and Hull operations to ensure timely closure of quality activities and drive continual improvements.
* Assist and support the internal audit schedule to ensure compliance and timely close‑out of improvement actions.
* Assist in the management of the Company’s Quality Archive Store to ensure continued compliance.
* Support Change Control activities ensuring outputs are correctly translated into procedures and communicated.
* Collate, interpret and report data from multiple sources to support business reporting activities, including the generation of Certificates of Analysis.
* Review goods returned for applicable disposition according to local procedural requirements.
* Input and manage data within existing Quality System databases.
* Present Quality system processes as SME and provide data to external regulatory bodies and senior management as required.
* Ensure efficient and effective Quality Compliance Release processes are operating site-wide through the development and implementation of procedures, training and guidance.
* Lead and coordinate NCs and Corrective Action & Preventative Action (CAPA) relating to function, escalating adverse trends and ensuring all specified actions are closed in a timely manner within the Quality Systems team.
* Provide Quality Compliance support to Operations / Project Teams to ensure changes are controlled within defined Quality Systems and meet customer needs.
* Assist in the creation and management of departmental measures that monitor section performance and drive continuous improvement.
* Assist as required in any potential or actual Field Safety Corrective Actions.
* Manage workload effectively to achieve personal and departmental objectives, and support other QC personnel with theirs.
* Provide an efficient and timely service to meet business requirements.
* Analyse data and establish conclusions based on available information.
* Lead, mentor and support the training and development of Quality Compliance Release personnel accordingly.
* Support the establishment and maintenance of appropriate documentation to support Quality Compliance Release requirements in alignment with global and local procedural requirements.
* Support internal and external audits as required.
* Support the identification and execution of continuous improvement initiatives and projects for the Quality Compliance Release process.
* Develop and manage relationships with personnel in all applicable functions and levels to ensure delivery of the highest standards of internal and external customer satisfaction.
Qualifications
* Degree level education or equivalent work experience in a relevant area.
* Advanced working knowledge of company products, processes, procedures, and personnel specifically associated with the QC release process.
* At least 5 years’ experience working within Quality Assurance, preferably within Medical Device or Pharmaceutical Industry.
* Good working understanding of the Medical Device Directive, GxP, ISO 9001, ISO 13485, and 21 CFR Part 820.
* Strong analytical and communication skills, with ability to manage personal and colleague workload to maintain high standards.
* Good understanding of the impact of the department on the business.
* Knowledge of product liability, alleged adverse incidents, and potential Field Safety Actions.
* Proficient in Microsoft Word and Excel, with good written English skills.
* Experience with MS Excel, Word, Outlook, Visio.
* Advanced understanding of SmartSolve and SAP user systems, including experience in UAT testing and system design requirements.
* Experience in data analysis and reporting.
Benefits
* Generous annual bonus and pension schemes.
* Share options.
* Flexible vacation and time off, including paid holidays and paid volunteering hours.
* Private health and dental plans, healthcare cash plans, income protection, life assurance.
* Hybrid working model (for most professional roles).
* Hands‑on, team‑customised, mentorship training.
* Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes, and many other employee discounts.
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