The ideal candidate is detail-oriented, highly organized, and capable of working effectively in a fast-paced, regulated environment while collaborating closely with cross-functional teams.

Key Responsibilities:
Sample Management & Laboratory Support

• Coordinate the receipt, collection, preparation, distribution, and delivery of samples to support QC testing activities.
• Track and manage samples using the Laboratory Information Management System (LIMS) to maintain accurate chain-of-custody records.
• Support shipping, storage, and disposal activities for raw materials, in-process materials, and drug substance samples.
• Maintain sample inventories and ensure timely processing and documentation.

Quality Control Operations

• Support the QC Reference Standard Program, including inventory management, storage, reconciliation, and distribution of reference standards to laboratory personnel.
• Perform routine laboratory support functions, including equipment maintenance, inventory monitoring, and sample reconciliation activities.
• Assist with laboratory housekeeping and organization to maintain a compliant and efficient work environment.
• Support routine QC activities as assigned by management.

Compliance & Documentation

• Perform all duties in accordance with cGMP requirements, company procedures, and regulatory standards.
• Maintain accurate and complete documentation related to sample management, inventory control, and laboratory activities.
• Communicate work progress, issues, and priorities effectively to supervisors and team members.

Operational Support

• Support business needs through flexible scheduling, including weekends, holidays, overtime, and shift coverage as required.
• Collaborate with QC personnel and cross-functional teams to ensure timely completion of laboratory operations.

Qualifications:
Required

• Associate degree, or equivalent combination of education and experience.
• 0–2 years of experience in a laboratory, manufacturing, quality, or related environment.
• Strong attention to detail and organizational skills.
• Effective verbal and written communication skills.
• Basic computer proficiency and ability to learn laboratory systems and databases.
• Ability to work independently and as part of a team.

Preferred

• Experience working in a pharmaceutical, biotechnology, medical device, or other regulated industry.
• Familiarity with cGMP regulations and quality systems.
• Experience using a Laboratory Information Management System (LIMS).
• Knowledge of laboratory inventory management and sample handling practices.

Working Conditions:

• Ability to work flexible schedules, including 4-day or 5-day workweeks, weekends, holidays, early and late shifts, overtime, and occasional on-call support.
• Work is performed in a laboratory and regulated manufacturing environment requiring adherence to safety and compliance standards