Job Description

Serves as the key coordinator for activities involving an external microbial services vendor, supporting GMP manufacturing operations. Collaborates with cross-functional teams including Analytical Sciences, Engineering, Process Sciences, and Manufacturing to ensure efficient and compliant execution of microbial testing workflows.

Morrisville, North Carolina

Contract (6 Months)

Pay: $40-42/hr

Key Responsibilities:

• Lead weekly internal planning meetings and represent the team in all interactions with the external vendor.
• Act as the main point of contact for the vendor’s project manager, ensuring clear and consistent communication.
• Organize and oversee sample collections, site visits, and other vendor-related logistics in partnership with internal manufacturing teams.
• Communicate operational needs to the Manufacturing Scheduler to maintain alignment with production timelines.
• Enter sample submissions into the vendor portal and extract data for internal use, including trending and reporting as needed.
• Provide support for environmental investigations and corrective actions as requested by Manufacturing or Analytical Sciences.
• Manage multiple projects simultaneously, meeting critical deadlines and escalating issues to ensure timely resolution.
• Ensure all activities comply with cGMP standards, with a focus on microbial testing such as bioburden, endotoxin, and environmental/personnel monitoring.

Qualifications:

• Bachelors Degree preferred.
• Proven experience in QC microbiology, including sample collection and testing, within a cGMP biotech or pharmaceutical setting.
• Working knowledge of environmental monitoring practices and microbial control in regulated environments.
• Experience with scheduling and project tracking tools is preferred.
• Strong organizational skills with the ability to handle high workloads and competing priorities effectively.
• Skilled in cross-functional collaboration, problem-solving, and conflict resolution within team environments.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Job Tags

Similar Jobs