Quality Assurance Compliance, Senior Associate
Company: Jubilant HollisterStier Spokane
Location: Spokane
Posted on: January 12, 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. * Relocation maybe provided. Position is located in
Spokane, WA. The Senior Associate, Quality Compliance will manage
and oversee JHS client and regulatory audit programs, perform
supplier risk assessments and review specifications for criticality
to ensure supplier qualification is appropriate. Essential
responsibilities include but are not limited to: * Responsible for
staying current on all regulations regarding audit compliance. *
Ensure company policies and expectations are well understood and
systems are ready for audit and inspection. * Develop audit metrics
to be used for management reviews. * Develop tour and SME staff,
ensuring consistency of audits. * Schedule, coordinate, host and
manage client audits. * Manage the process for completion of
observation responses for client audits. Evaluate responses for
content, accuracy and appropriateness of proposed corrective
actions. * Host and manage Regulatory audits. * Assist in the
maintenance of the Approved Supplier List. * Maintain Department
Procedures and complete department-related Change Controls, CAPAs
and Deviations. * Review and approve material Specifications *
Evaluate suppliers via risk assessment. Qualifications: * Bachelors
of Science required OR 5 years of experience in lieu of degree. *
Must have minimum of 2 years Quality - Unit experience. *
Pharmaceutical and FDA Regulated Industry Experience required. * 5
years of experience in facilities with aseptic processing or cGMPs
required. * Supervisor and laboratory experience is desired. *
Physical Requirements: Prolonged sitting and standing. Exposure to
allergens. 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! https://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@jubl.com
Keywords: Jubilant HollisterStier Spokane, Spokane , Quality Assurance Compliance, Senior Associate, Other , Spokane, Washington
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