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Manufacturing Compliance Specialist

3 months ago

Woodinville, United States Inventprise Inc. Full time
Job DescriptionJob DescriptionSalary: $33.00 - $38.00 / Hr DOE

Title: Manufacturing Compliance Specialist


Overtime Status: Non-Exempt


Employment Status: Full-Time


Pay Range: $33.00 - $38.00 /hourly DOE


The hiring pay range for this position is $33.00 - $38.00 per hour based on skills, education, and experience relevant to this role.


Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.  


At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:


Benefits:

Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:


  • Medical, Dental, Vision, FSA, or HSA:  Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents.  Medical plans are currently provided through Premera Blue Cross.
  • 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
  • Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
  • Paid Holidays: Inventprise offers 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.
  • Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.



Summary: 


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.


Essential Functions:


  • 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.


Non-Essential (Additional) Functions:


  • 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 workflow


Educational Pre-requisites:


  • High School Diploma or equivalent.
  • Bachelor’s degree or Biotech certificated, quality systems regulations knowledge and clean room experience preferred but not required, equivalent combination of education, training, and experience will also be considered.
  • Minimum 3 year of experience working withing a federally regulated industry specifically withing 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 lift 30 pounds with assistance, push, pull, bend and stand for prolonged periods of time.
  • Ability to gown in and work in a clean room environment for extended periods of time.
  • Flexible, have the availability to work hours outside of scheduled shift hours to support production and/or maintenance activities.


Mental Demands:


  • Solid interpersonal and teamwork skills, and the ability work cross-functionally to collaborate with various leadership levels.
  • Must maintain high level organization, alertness and acuity for analytical review and processing of documentation, daily.
  • Attention to detail and accuracy for record keeping and documentation is mandatory.
  • Exhibit a high level of flexibility and ability to always multitask while working in an ever changing environment where priorities will shift.

Working Conditions:


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


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.