Specialist I/II/Sr, Tech Services - ABU

Company: Jubilant HollisterStier Spokane
Location: Spokane
Posted on: January 14, 2021

Job Description:

Jubilant HollisterStier LLC provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is owned by Jubilant Life Sciences. This position of Specialist I/II/ Senior Specialist of Technical Services has responsibility for technical transfer and implementing processing improvement activities at JHS-Spokane for Allergy Business Unit projects. (The M07 level may also have responsibility for supervising and/or mentoring other personnel within the group). The successful candidate will communicate heavily with other functional teams, leading to effective resolution of issues. Essential responsibilities include: * Support Project Managers and ABU R&D on project teams with primary responsibility for manufacturing process design and process validation. * Utilize Quality by Design (QbD) tools to ensure robust, deviation-free processes. * Review data summaries and assess the data for potential trends or conditions that should be taken into consideration when implementing new products or processes. * Know and apply cGMP requirements and recommendations from many different agencies as they pertain to the technology transfer of products and processes. * Prioritize and multi-task among many projects of varying importance. This may include off-shift work as necessary. * Provide necessary summaries and reviews for regulatory and customer inspectors/auditors; provide responses to written observations made by the inspector/auditors, and ensure that all corrective actions are completed as described and within the timeframe given in the response. Qualifications: * Bachelors Degree in hard science or other technical field required. * Specialist I - no experience required. * Specialist II - minimum 2 years' experience transferring new products, processes and/or process validation in a regulated industry required. (Minimum 5 years of this experience in FDA-regulated environment for the Senior Specialist level) * Prior pharmaceutical experience preferred for Specialist I or II (required for Senior Specialist) * Proficiency in Microsoft Word, Excel and PowerPoint required. * Physical Requirements: Prolonged sitting. Ability to work in clean-room environment required. Jubilant HollisterStier is a great place to grow! If you're up for a rewarding challenge, we invite you to take the first step and apply today! http://www.jubilantcareer.jubl.com Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability. If you require assistance applying for a position, please contact our HR Department at: HResources@jhs.jubl.com

Keywords: Jubilant HollisterStier Spokane, Spokane , Specialist I/II/Sr, Tech Services - ABU, Other , Spokane, Washington