Project Coordinator, Tech Ops
CSL, Holly Springs, NC, United States
Position Summary
The Project Coordinator supports the execution of pharmaceutical projects across development, manufacturing, regulatory affairs, and quality functions. This role ensures effective coordination of activities, documentation, and timelines while maintaining compliance with regulatory requirements.
Responsibilities
Coordinate project activities across cross‑functional teams and Integrated Project Teams (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 such as MS Project or Smartsheet.
Support audits and inspections by ensuring proper documentation and traceability.
Qualifications
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 a 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 development, manufacturing, regulatory affairs, and quality functions. This role ensures effective coordination of activities, documentation, and timelines while maintaining compliance with regulatory requirements.
Responsibilities
Coordinate project activities across cross‑functional teams and Integrated Project Teams (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 such as MS Project or Smartsheet.
Support audits and inspections by ensuring proper documentation and traceability.
Qualifications
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 a 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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