Specialist I/II/Sr, Tech Services - ABU
Company: Jubilant HollisterStier Spokane
Location: Spokane
Posted on: January 14, 2021
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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
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