Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **POSITION SUMMARY:** A QC Technical Specialist is required for the QC department for a purification and aseptic manufacturing plant and packaging plant in Grifols Worldwide Operations (GWWO). This role offers a chance to work in a state-of-the-art facility, in an innovative Biotechnology company with excellent career development opportunities, and a clear and committed patient focus. The role will be responsible for providing technical expertise and support functions for the 3 teams within Quality Control, Chemistry, Microbiology and Incoming QC. Reporting directly to the Quality Control (QC) Systems Lead, as part of the QC Technical Team, the role will have a focus on method transfers, new product introduction, systems support, equipment validation, continuous improvement and implementing a lean culture. **KEY RESPONSIBILITIES:** + Expert in a wide variety of analytical techniques including but not limited to Protein Determination Assays, Immunoassays, Chromatography assays ( GC and HPLC) Microbiological and Aseptic Techniques. + Familiar with incoming/release testing of raw materials and packaging materials. + Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. + Responsible for trouble shooting, problem solving, providing technical guidance and applying expertise and critical thinking to independently resolve technical issues. + Lead training of staff on technical aspects of job as required. + Develop, revise and implement procedures that comply with appropriate regulatory requirements. + Qualification of analytical equipment and Computerised systems validation and related testing functions. + Co-ordinates & plans activities related to the successful method transfers and optimization of QC methods into GWWO. + Compliance with Standard Operating Procedures and Registered specifications. + Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP. + Ensure timely completion of Laboratory Investigation Reports, Out of Specification (OOS) investigations and deviations. + Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing. + Trending of data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications. + Participate in regulatory agency inspections as required. + Plan and implement procedures and systems to maximize operating efficiency. + Manage and contribute to the achievements of department productivity and quality goals. + Ensure the laboratory is operated in a safe manner. + Travel where required including foreign travel as part of the role. **KEY COMPETENCIES:** + Skilled in the use of problem-solving tools/techniques + Excellent written and verbal communication skills + Experience with deviation investigation, risk assessment and CAPA implementation. + Experience with Change Control process and implementation. + Experience with analytical equipment qualification. + Experience in method transfer, validation and verification. + Knowledge of applicable Regulatory requirements + Experience with Regulatory inspections and interacting with inspectors + Ability to handle multiple projects and deadlines, with experience working with cross-functional teams and influencing decision + Good communication skills and the ability to collaborate at a variety of levels within and outside the organisation + Ability to work on own initiative without direct supervision + Ability to work accurately under pressure **Knowledge & Skills:** + Experienced in protein determination, chromatography and microbiology. + Experience with variety of analytical softwares including Empower and Tiamo. + Strong background in method transfer and qualification. + Experience in analytical equipment and computerised system qualification. + Excellent verbal and written communication. Must be able to read, write, and speak English. + Strong understanding of Data Integrity and ALCOA principles. + Must have strong technical writing skills. + Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. + Strong organizational, analytical and problem-solving skills. + Ability to analyze details and perform structured decision-making on a daily basis. + Experience of managing project groups and leading high performing teams and delivering results desirable + Experience of raw material testing equipment including NIR desirable but not essential + Experience with SAP desirable but not essential + Knowledge of Computerised System Validation regulatory requirements desirable but not essential **Qualifications:** + Bachelor’s degree in technical discipline (e.g. biochemistry, chemistry, microbiology) or equivalent. + Minimum of 5 years’ experience in a pharmaceutical/healthcare Laboratory. + Internal Auditor Certification desirable but not essential + Preferable 2 Years’ experience in a similar role **Our Benefits Include:** + Highly competitive salary + Group pension scheme - Contribution rates are 5% employer and 5% employee + Private Medical Insurance for the employee + Ongoing opportunities for career development in a rapidly expanding work environment + Succession planning and internal promotions + Education allowance + Wellness activities - Social activities eg. Padel, Summer Event We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you \#LI-FD1 **Req ID:** 520126 **Type:** Regular Full-Time **Job Category:**