Quality Assurance Compliance, Senior Associate

Company: Jubilant HollisterStier Spokane
Location: Spokane
Posted on: January 12, 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. * 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