Job Information
Jubilant HollisterStier 34632 Lead QA Off shift in Spokane, Washington
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, Growing
We 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 - 1830
Compensation:
This position pays $67,725 - $85,514 per year, depending on experience, with opportunity for growth, promotion and annual raises.
Benefits:
- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
- Life, AD&D, Short and Long Term Disability
- 401(k) with company match
- Generous paid time off plan
- Employee Assistance Program
Optional Benefits:
Voluntary