Jubilant HollisterStier LLC
Lead, QA Off Shift
Jubilant HollisterStier LLC, Spokane, Washington, United States, 99254
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, 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 a proud member of the Jubilant Pharma family.Our Promise: Caring, Sharing, GrowingWe will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.
Job Description:The
Lead, QA Off Shift
will be responsible for performing and completing QA deliverables needed over the weekend to support manufacturing output. For example, QA AQL inspections, QA incoming inspections, QA release of materials, QA documentation issuances, QA label control issuance, etc. To accomplish this purpose, the lead will refer to existing procedures and complete the appropriate training to perform and complete necessary tasks.Provide real time problem solving support to the QA off shift supervisor when potential quality impacting events occur in alignment with existing guidance documents, regulations, and procedures. The lead will escalate events which require more senior level engagement and propose solutions.Collect and report metrics to the QA off shift supervisor for site compliance. Elevate and propose responses to trends.Propose new systems needed to facilitate weekend objectives. Implement approved solutions for continuous improvement of QA.Attend meetings and participate in discussions as requested by the QA off shift supervisor.Ensure training is up to date prior to task execution.Execute approver responsibility for documents within quality systems as appropriate for a QA Lead.Participate in multidisciplinary teams to achieve site objectives as required.Review and approve assigned Standard Operating Procedures, Protocols, and Acceptance Reports associated with facility, systems and manufacturing support from the perspective of compliance with applicable regulatory requirements, and provide input/comments/changes as needed.Qualifications:High school or equivalent required. Bachelors of Science Degree in a scientific discipline (or 4 years' experience in lieu of degree) required.Minimum of 5 years related experience or Bachelor's degree and 2 years of experience.Understanding of manufacturing/processing flow at JHS-S and of governing CFR guidelines.Basic knowledge of quality controls implemented to mitigate risk to product/patients.Proficiency in Microsoft Word, Excel and PowerPoint required.Physical Requirements: 14/14 Corrected near-point, pass color deficiency test, prolonged standing and sitting.Shift:
Friday - Sunday 0600 - 1830Compensation & Benefits:This is an
on-site,
full-time position located in Spokane, WA.Hiring Wage: $67,725 - $85,514 per year depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.Full Wage Range: $67,725 - $90,000 per year.
Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role
Medical, Dental, Vision, Flexible Spending and Health Savings AccountsLife, AD&D, Short and Long Term Disability401(k) with company matchGenerous paid time off planEmployee Assistance ProgramOptional Benefits:Voluntary Life and AD&D for employee & familySupplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)Pet InsuranceID Theft ProtectionPerk Spot Discount ProgramUnlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!https://jubilantcareer.jubl.com/*Please click on the Spokane, Wa. Link*Jubilant HollisterStier is an EEO/AA Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If you require assistance applying for a position, please contact our HR Department at:Human.Resources@jubl.com
Job Description:The
Lead, QA Off Shift
will be responsible for performing and completing QA deliverables needed over the weekend to support manufacturing output. For example, QA AQL inspections, QA incoming inspections, QA release of materials, QA documentation issuances, QA label control issuance, etc. To accomplish this purpose, the lead will refer to existing procedures and complete the appropriate training to perform and complete necessary tasks.Provide real time problem solving support to the QA off shift supervisor when potential quality impacting events occur in alignment with existing guidance documents, regulations, and procedures. The lead will escalate events which require more senior level engagement and propose solutions.Collect and report metrics to the QA off shift supervisor for site compliance. Elevate and propose responses to trends.Propose new systems needed to facilitate weekend objectives. Implement approved solutions for continuous improvement of QA.Attend meetings and participate in discussions as requested by the QA off shift supervisor.Ensure training is up to date prior to task execution.Execute approver responsibility for documents within quality systems as appropriate for a QA Lead.Participate in multidisciplinary teams to achieve site objectives as required.Review and approve assigned Standard Operating Procedures, Protocols, and Acceptance Reports associated with facility, systems and manufacturing support from the perspective of compliance with applicable regulatory requirements, and provide input/comments/changes as needed.Qualifications:High school or equivalent required. Bachelors of Science Degree in a scientific discipline (or 4 years' experience in lieu of degree) required.Minimum of 5 years related experience or Bachelor's degree and 2 years of experience.Understanding of manufacturing/processing flow at JHS-S and of governing CFR guidelines.Basic knowledge of quality controls implemented to mitigate risk to product/patients.Proficiency in Microsoft Word, Excel and PowerPoint required.Physical Requirements: 14/14 Corrected near-point, pass color deficiency test, prolonged standing and sitting.Shift:
Friday - Sunday 0600 - 1830Compensation & Benefits:This is an
on-site,
full-time position located in Spokane, WA.Hiring Wage: $67,725 - $85,514 per year depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.Full Wage Range: $67,725 - $90,000 per year.
Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role
Medical, Dental, Vision, Flexible Spending and Health Savings AccountsLife, AD&D, Short and Long Term Disability401(k) with company matchGenerous paid time off planEmployee Assistance ProgramOptional Benefits:Voluntary Life and AD&D for employee & familySupplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)Pet InsuranceID Theft ProtectionPerk Spot Discount ProgramUnlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!https://jubilantcareer.jubl.com/*Please click on the Spokane, Wa. Link*Jubilant HollisterStier is an EEO/AA Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If you require assistance applying for a position, please contact our HR Department at:Human.Resources@jubl.com