Senior Process Specialist, AP, Weekdays

2 weeks ago

Clayton, North Carolina, United States BioSpace, Inc. Full time
Job Overview

About Our Organization

At BioSpace, Inc., we are dedicated to making a significant impact in the healthcare industry. With a legacy of excellence, we provide innovative solutions that enhance the quality of life for individuals globally. Our commitment to our employees fosters a dynamic work environment where careers can flourish, and contributions are valued.

Our facilities are pivotal in the production of essential healthcare products, and we pride ourselves on our state-of-the-art manufacturing processes. Joining our team means becoming part of a community of professionals who are passionate about their work and the difference it makes.

What We Provide:
  • Competitive salary and annual performance incentives for all roles
  • Generous paid time off, including 14 holidays
  • Comprehensive health benefits, including medical, dental, and vision coverage from day one
  • Guaranteed 8% contribution to retirement plans, with additional matching options
  • Family-oriented benefits, including paid parental leave and family medical leave
  • Access to company-sponsored pharmaceutical products
  • Educational assistance programs
  • Life and disability insurance
  • Incentives for employee referrals
At BioSpace, Inc., we offer the resources, mentorship, and opportunities necessary for personal and professional growth. Are you ready to unlock your potential? Join us in making a meaningful difference.

The Role

Act as the process subject matter expert (SME) for designated production areas. Support personnel, equipment, and processes to align with business and regulatory standards. Serve as a leader and mentor for junior team members, assisting with their training and development.

Key Relationships

Collaborate with management and directors, engaging with stakeholders related to your area as well as across various departments.

Core Responsibilities
Oversee content within your area, providing process expertise, conducting periodic reviews, and managing validation processes and reportingUtilize technical knowledge of assigned processes to drive continuous improvement, enhance productivity, and reduce costsFacilitate technical oversight for processes, including assessing deviations, conducting root cause analyses, and implementing process enhancementsAnalyze process and maintenance data to recommend and evaluate solutions for ongoing improvements using Lean and Six Sigma methodologiesAct as the technical authority for assigned processes during audits and inspectionsShare best practices and collaborate with other departments and facilitiesSupport various areas with your expertise in the assigned production/process domainIdentify and implement process improvements for complex issues as the SME for your areasIntegrate new technologies into processes, ensuring compliance with regulatory standardsAdhere to all safety and environmental protocols while performing dutiesOther responsibilities as assignedPhysical Requirements

Ability to work in a collaborative office environment with potential distractions. Willingness to travel up to 20% of the time, subject to role-specific requirements.

Qualifications
Bachelor's degree in engineering, technology, or a related field from an accredited institution is requiredAn Associate's degree in a relevant field may be considered with a minimum of seven years of manufacturing experienceA High School Diploma (GED) may be accepted with at least nine years of manufacturing experienceA minimum of five years of manufacturing experience is required, preferably in a pharmaceutical settingStrong investigative and systematic problem-solving skills are essentialExperience and training in LEAN manufacturing are requiredExcellent written communication, investigative writing, and computer skills are necessaryAbility to comprehend complex product documentation and standard operating procedures is requiredProven capability in driving continuous improvements using Lean and Six Sigma tools is essentialDemonstrated expertise in planning, organizing, managing execution, and evaluating results is requiredComprehensive understanding of change control systems and Quality Management Systems (QMS) is necessaryThorough knowledge of validation processes is required, with product/tech transfer experience preferredGeneral familiarity with regulatory audits and inspections is necessarySolid understanding of relevant electronic manufacturing systems and master data is requiredProven knowledge of adult learning methodologies and the ability to train and coach others effectively is essentialWe are committed to an inclusive recruitment process and equal opportunity for all applicants.

At BioSpace, Inc., we strive to be the best organization for the world, recognizing that this is only achievable through a diverse workforce with varied perspectives and backgrounds. We are dedicated to fostering an inclusive culture that celebrates the diversity of our employees and the communities we serve. Together, we are making a difference.

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