Project Coordinator, Tech Ops
BioSpace, Holly Springs, NC, United States
Position Description Summary
The Project Coordinator supports the execution of pharmaceutical projects across areas such as development, manufacturing, regulatory affairs, or quality. The role ensures effective coordination of activities, documentation, and timelines while maintaining compliance with regulatory requirements.
Main Responsibilities & Accountabilities
Coordinate project activities across cross-functional teams (IPTs and Cross IPTs).
Track project milestones and deliverables to ensure on-time execution.
Support preparation and maintenance of project documentation in compliance with GxP requirements.
Organize project meetings, prepare agendas, and document minutes and action items.
Assist in risk tracking, issue escalation, and CAPA follow-up.
Maintain project plans using tools (e.g., MS Project, Smartsheet).
Support audits and inspections by ensuring proper documentation and traceability.
Qualifications & Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
2–5 years of experience in project coordination within pharma, biotech, or CRO environments.
Basic knowledge of GMP/GxP regulations.
Familiarity with clinical, manufacturing, or regulatory processes is a plus.
Experience with project management tools and document management systems (e.g., Veeva).
Strong organizational and documentation skills.
Key Skills
Understanding of regulated environments (GMP/GxP).
Strong coordination and communication skills.
Attention to detail and compliance mindset.
Ability to manage multiple priorities.
Team collaboration across scientific and operational functions.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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The Project Coordinator supports the execution of pharmaceutical projects across areas such as development, manufacturing, regulatory affairs, or quality. The role ensures effective coordination of activities, documentation, and timelines while maintaining compliance with regulatory requirements.
Main Responsibilities & Accountabilities
Coordinate project activities across cross-functional teams (IPTs and Cross IPTs).
Track project milestones and deliverables to ensure on-time execution.
Support preparation and maintenance of project documentation in compliance with GxP requirements.
Organize project meetings, prepare agendas, and document minutes and action items.
Assist in risk tracking, issue escalation, and CAPA follow-up.
Maintain project plans using tools (e.g., MS Project, Smartsheet).
Support audits and inspections by ensuring proper documentation and traceability.
Qualifications & Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
2–5 years of experience in project coordination within pharma, biotech, or CRO environments.
Basic knowledge of GMP/GxP regulations.
Familiarity with clinical, manufacturing, or regulatory processes is a plus.
Experience with project management tools and document management systems (e.g., Veeva).
Strong organizational and documentation skills.
Key Skills
Understanding of regulated environments (GMP/GxP).
Strong coordination and communication skills.
Attention to detail and compliance mindset.
Ability to manage multiple priorities.
Team collaboration across scientific and operational functions.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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