Manufacturing Compliance Specialist, cGMP Job at Inventprise Inc. in Woodinville

Salary: $33.00 - $38.00 / Hr DOE

About Inventprise

At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives—no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large-scale to Low and Middle Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We’re proud to have some of the world’s most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.

What the Role Offers - Manufacturing Compliance Specialist

The Manufacturing Compliance Specialist is responsible for manufacturing quality deliverables such as root cause analysis, change controls, CAPA, batch record review, and scheduling activities. Additionally, the Manufacturing Compliance Specialist serves as a mentor to members of the operations team, providing training and guidance for compliance related activities.

What You Need to Succeed

• Analyzes standard operating procedures (SOPs) for alignment with manufacturing methods and production records relative to company policies, regulatory authorities and company polices.
• Gathers data from various sources across the site to participate and/or lead root cause analysis (RCA) to determine the most likely cause of a non-conformance.
• Assess non-conformance events for impact to product quality, perform risk assessments, cause mapping and interview of participants.
• Suggested, initiates, and implements Change Requests (CRs) and/or Corrective and Preventative Actions (CAPAs) in collaboration with manufacturing team and Quality Assurance
• Collaborates with the Training group to identify opportunities for improvement that are identified regarding personnel training that result from investigation of nonconformance findings.
• Collaborates with stakeholders outside of manufacturing to schedule implementation and qualification of equipment and controls.
• Coordinates with external departments to ensure on time delivery of material release, batch record issuance and kit staging.
• Track, schedule, and assign preventative maintenance and calibration events to ensure tasks are completed prior to the due date.
• Daily or when necessary, goes in plant to review batch records and monitor the production process, workflows, personnel requirements, equipment needs and timing to ensure accurate scheduling for the success of on-time delivery.
• Aid in the identification, development, and maintenance of a production schedule to track daily, weekly, monthly and quarterly tasks for the purpose of tracking and reporting KPIs and provide visibility to external stakeholders to allow for tracking of annual goals and scheduling events that impact manufacturing such as maintenance events or automation upgrades.
• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective products.
• Assistance with inspection readiness efforts and providing Inspection support as required.
• Provide critical communications upward, downward, and across as deemed fit; manage compliance-related decisions– acquire feedback, input, and consult as required.
• Review and approve documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
  
• Adhere to applicable training requirements, as per Inventprise training policy (including formal GMP training).
• Adhere to applicable safety requirements, as per Inventprise safety procedures.
• Adhere to applicable employee conduct criteria, as per Inventprise Human Resources Manual.
• Capable of efficiently and effectively using computer-based technology to accomplish workflows.

Required Qualifications:

• High School Diploma or equivalent.
• Bachelor’s degree or Biotech certificate, quality systems regulations knowledge, and clean room experience preferred but not required, an equivalent combination of education, training, and experience will also be considered.
• Minimum 3 years of experience working within a federally regulated industry specifically within the Manufacturing, Quality, or Supply Chain Manufacturing areas.
• Extensive knowledge of SOPs and cGMPs within a regulated field.
• Proficient in Microsoft Office applications
  

Physical Demands:

• Must be present on site for all related responsibilities and be able to routinely perform activities as defined above.
• Must be able to stand for extended periods of time.
• Must be able to dress in sterile gowning in the form of scrubs and clean room coveralls.
• Ability to handle and work with potentially hazardous chemicals per standard operating procedure.
• Must be able to lift up to 30 pounds.
  

Mental Demands:

• Excellent oral and written communication skills.
• Highly organized with an attention to detail
• Must maintain a high level of alertness and acuity for analytical review and processing of documentation, daily.
• Able to work independently with changing priorities.
  

Working Conditions:

• Extended periods of time on the computer.
• Extended periods of time on your feet.
• Working in a warm environment wearing sterile gowning.
• Working with chemicals per standard operating procedure.

Estimated Base Salary: $33.00 - $38.00 /hourly DOE

Benefits:

• Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
• Paid Time Off: Generous PTO, in addition to paid holidays.
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock plans.

Our People-First Philosophy

At Inventprise, you’ll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.

Equal Opportunity Employer

Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.