Specialist, QA Oversight

Jubilant HollisterStier CMO; Spokane (WA); On-site; USD 74,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental & Vision coverage

FSA/HSA

Life & AD&D Insurance

Short-Term & Long-Term Disability

Job summary

Jubilant HollisterStier Spokane is seeking a QA Oversight Specialist to ensure manufacturing and quality control operations comply with regulatory standards. You will provide real-time floor support and act as a liaison between production teams and Quality Assurance.

The role includes on-the-floor oversight in aseptic environments, deviation investigations, batch record reviews, and driving continuous improvement.

Qualifications

• Bachelor of Science Degree or 4 years of technical manufacturing experience in lieu of degree.
• Minimum of 2 years related experience enforcing compliance in regulated industry required or 3 years of direct pharmaceutical experience required
• FDA Regulated Industry required
• Proficiency In Microsoft Word, Excel and PowerPoint Required
• In-Depth Understanding of the Relationship Between Regulatory Requirements, Operating Procedures, And Ensuring Compliance in A Production Environment required
• Able To Follow Detailed Instructions required
• Excellent Interpersonal Skills Required.
• Able to Navigate Differing Opinions required
• Problem Solving Skills required

Responsibilities

• Regulatory Compliance Ensure all procedures and practices within Manufacturing and Quality Control align with applicable US and European regulatory standards.
• On-the-Floor Oversight Conduct real-time oversight of Manufacturing and QC operations while in controlled aseptic environments to verify that products meet labeling, dating, and packaging requirements per SOPs and cGMP.
• Observation and Reporting:Provide daily, weekly, and monthly summaries of floor observations, respond to findings, and ensure timely completion of corrective actions.
• Problem Identification and Mitigation: Recognize potential quality issues, review and approve mitigation strategies, and collaborate with department supervisors to resolve deficiencies in product quality or systems.
• Deviation Investigation: Ensure investigations into facility or support system deviations are thorough, accurate, and adequately documented.
• Independent and Collaborative Problem Solving Demonstrate the ability to solve complex problems both independently and within cross-functional teams.
• Aseptic Processing Oversight: Provide QA oversight for aseptic processing while present within controlled environment to ensure sterility and compliance. Obtaining and maintaining access to controlled environment is required.
• Training Support: Assist in onboarding and training new QA Oversight personnel to maintain consistency and quality standards.
• Quality System Review: Review and approve quality system records, ensuring accuracy and regulatory compliance.
• Continuous Improvement: Proactively revise SOPs related to job functions to align with evolving industry standards and best practices.
• On the floor batch record review: Perform daily review of on the floor manufacturing batch records to ensure compliance with ALCOA++ principles.
• Ability to don sterile gowns.

Skills

MS Word

MS Excel

PowerPoint

Regulatory knowledge

Problem solving

Interpersonal skills

Education

Bachelor of Science Degree

4 years of technical manufacturing experience in lieu of degreerequired

Tools

Microsoft Office

Job description

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next
As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.
We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.
For the Builders, Innovators, and Doers — This Is Your Place
If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally.
Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.
  

If you want to build something meaningful with a team that values your drive, skills, and ideas — you belong here.
Job Description: The QA Oversight Specialist plays a critical role in ensuring that all manufacturing and quality control operations meet established quality standards and regulatory requirements. This position provides daily on-the-floor support to all functions associated with Manufacturing and Quality Control, serving as a key liaison between operational teams and the Quality Assurance department. The specialist is responsible for the evaluation and review of ongoing operations, ensuring compliance, consistency, and continuous improvement across all quality-related activities. This includes oversight of facility operations, systems, and manufacturing support functions such asMetrology, Engineering, Maintenance, and Information Systems (IS).
Essential responsibilities include but are not limited to:

• Regulatory Compliance Ensure all procedures and practices within Manufacturing and Quality Control align with applicable US and European regulatory standards.
• On-the-Floor Oversight Conduct real-time oversight of Manufacturing and QC operations while in controlled aseptic environments to verify that products meet labeling, dating, and packaging requirements per SOPs and cGMP.
• Observation and Reporting:Provide daily, weekly, and monthly summaries of floor observations, respond to findings, and ensure timely completion of corrective actions.
• Problem Identification and Mitigation: Recognize potential quality issues, review and approve mitigation strategies, and collaborate with department supervisors to resolve deficiencies in product quality or systems.
• Deviation Investigation: Ensure investigations into facility or support system deviations are thorough, accurate, and adequately documented.
• Independent and Collaborative Problem Solving Demonstrate the ability to solve complex problems both independently and within cross-functional teams.
• Aseptic Processing Oversight: Provide QA oversight for aseptic processing while present within controlled environment to ensure sterility and compliance. Obtaining and maintaining access to controlled environment is required.
• Training Support: Assist in onboarding and training new QA Oversight personnel to maintain consistency and quality standards.
• Quality System Review: Review and approve quality system records, ensuring accuracy and regulatory compliance.
• Continuous Improvement: Proactively revise SOPs related to job functions to align with evolving industry standards and best practices.
• On the floor batch record review: Perform daily review of on the floor manufacturing batch records to ensure compliance with ALCOA++ principles.
• Ability to don sterile gowns.
  

Qualifications:

• Bachelor of Science Degree or 4 years of technical manufacturing experience in lieu of degreerequired
• Minimum of 2 years related experience enforcing compliance in regulated industry required or 3 years of direct pharmaceutical experience required
• FDA Regulated Industry required
• Proficiency In Microsoft Word, Excel and PowerPoint Required
• Mechanical Aptitude Desired
• In-Depth Understanding of the Relationship Between Regulatory Requirements, Operating Procedures, And Ensuring Compliance in A Production Environment required
• Able To Follow Detailed Instructions required
• Excellent Interpersonal Skills Required.
• Able to Navigate Differing Opinions required
• Problem Solving Skills required
  

Other Physical Requirements:

• Exposure to allergens
• Working in Aseptic areas
• Prolonged standing and sitting
• Don sterile gowns
  

Location: Spokane, WA — On Site, Full- -Time
Shift: Monday-Wednesday EO Thursday | 6:00AM-6:00PM
Compensation & Benefits That Start on Day One — Because Your Well Being Matters
Hiring Wage: $74,155.00 – $100,323.44, with opportunities for growth, promotion, and annual raises.
At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
Employee Assistance Program

Unlock Your Potential
EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Our Promise: Caring, Sharing, Growing
We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.