Quality Control Scientist, Technical Support

14.01.2020 | Employee | 100%

Quality Control Scientist, Technical Support

Share This Page Quality Control Scientist, Technical Support Qlty Assurance Methods Couvet, , Switzerland Full time R1519816_EN 12/23/2019 10:03:28 AM Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. 1. Purpose and Scope of Position The Scientist is part of the Technical Support team of the Quality Control (QC) department of Celgene, Switzerland. The QC department is responsible for testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms manufactured at the site. The Scientist will provide technical and scientific expertise to support acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories. Additional duties will include performing superuser activities for the laboratory computerized systems, representing QC in cross-functional projects (e.g. for new product implementation) and participating in internal and external audits as Subject Matter Expert (SME). This position is primarily located at the Celgene site in Boudry. The Scientist may also be assigned responsibilities for activities or systems located at the Celgene site in Couvet. 2. Required Competencies: Knowledge, Skills, and Abilities · Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements. · Excellent scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS and IR techniques. · Experience of analytical testing according to Ph. Eur. and USP requirements. · Experience in analytical method transfers and analytical method validation/verification. · Experience in laboratory equipment qualification. · General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio). · Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS). · Good knowledge of Data Integrity principles, familiar with audit trail review requirements. · Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments. · Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations. · Takes a structured and analytical approach to problem solving. Is familiar with problem-solving and investigation tools and methodologies. · Ability to work collaboratively and cross-functionally in project teams. · Fluent in English or French and professional command of the second language (written and verbal). 3. Duties and Responsibilities · Is responsible for acquisition and qualification of new analytical equipment: - Works cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC laboratories. - Owns the change control, leads or supports risk assessments. - Performs feasibility experimental work as needed. - Configures user profiles and methods on the instrument. - Collaborates with Validation and Sourcing to define requirements and contracts for the periodic maintenance and requalification of the equipment. · Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory: - Owns deviations. Leads or supports laboratory investigations in case of out of specification or out of trend result. - Writes investigational testing plans to identify laboratory root cause. - Defines corrective and preventive actions (CAPA). · Represents QC in project teams (e.g. for new product introductions to the site): - Represents QC in cross-functional project teams, interacting with Project Management Office, Manufacturing, Analytical Development, Analytical Science and Technology. - Supports QC management in identifying needs for new equipment and assessing impact on laboratory systems and processes as well as on resource planning. - Leads or supports risk assessments, owns change controls. - Reviews method transfer plans. Performs or supports feasibility experimental work as needed. Supports method transfer, method verification and method validation activities. · Superuser of laboratory computerized systems: - Administers user profiles and access to the systems. - Defines requirements and performs audit trail reviews, assures adherence to data integrity principles. - Authors instrument/system operating procedures, trains QC analysts on use of the system. - Performs master data management activities in computerized systems (LIMS, Oracle, Empower). · Maintains the GMP status of the laboratory and analytical methods: - Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures. - Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required. - Actively participates in inspections by health authorities and in corresponding preparation. - Performs other tasks as assigned. 4. Education and Experience · BS degree in Life Sciences, Chemistry, or equivalent; · 5 years of work experience in a GMP environment (pharmaceutical industry). Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Working with Us By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move. Come Meet Our Team Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. For US Applicants Only Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. 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14.01.2020
Employee, 100%

Contact

Bristol Myers Squibb

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Bristol Myers Squibb

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896
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