Laboratory Operations Coordinator

Summary of Primary Responsibilities:

The Laboratory Operations Lead plays an integral role in ensuring smooth functioning of laboratory activities, overseeing the day-to-day operations while maintaining focus on efficiency, compliance and safety. Ensuring scheduling supports business requirements for all testing needs- in process, finished goods, stability, raw materials and engineering support. Facilitate communication between laboratory staff and other departments. Responsible for all sample handling. Responsible for all inventory ordering and expiry requirements. Foster a team-oriented atmosphere where communication is key.

Specific Responsibilities:

• Oversee receipt, storage, labeling, documentation, and distribution of all samples received in the QC laboratories (Chemistry and Microbiology).

• Oversee the sample receipt log.

• Monitor testing turnaround time and provide metrics weekly.

• Prepare and ship samples to external laboratories and follow up to ensure test results are received back per timeline.

• Order materials and laboratory supplies following weekly inventory.

• Communicate with external departments (e.g. Manufacturing, Packaging, Engineering, and R&D) to address and resolve issues identified during samples receipt.

• Update SOPs from drafts provided.

• Oversee the stability master schedule to ensure new stability samples are properly enrolled in the stability program and the master schedule and documentation updated and filed accordingly.

• Submit stability samples to the laboratories as scheduled per established pull timepoints.

• Oversee monitoring of stability storage conditions, stability samples and status of laboratory test results ensuring stability programs' progress according to the established protocols

• Draft stability summary tables and ensure they are reviewed and filed on time.

• Prepare metrics for the monthly stability meeting.

• Escalate unusual observations, deviations or any incidence of non-compliance with established protocols or procedures.

• Implement and oversee maintenance schedules for laboratory equipment to ensure optimal performance and longevity.

• Responsible for coordination of laboratory scheduling as needed

• Propose ideas for laboratory optimization. Participate in other projects as assigned

Job Complexity:

Responsible for a complex work product

Supervisory Responsibilities:

None

Experience, Knowledge, and Skills Required:

• Bachelors Degree or equivalent experience

• Good understanding of word and excel

• Self-motivated with good time management and organizational skills

• Good attention to detail and general knowledge of GMP

• Must be comfortable working in a fast-paced environment with ability to adjust workload based upon changing priorities.

• Ability to handle multiple priorities and meet established deadlines

• Ability to work independently

• Good communication and writing skills

• Laboratory administrative experience a plus

• Ability to work flexible hours to complete work activities

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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.