Job Description
Job Summary:
- The QC Laboratory Support Technician plays a key role in supporting Quality Control laboratory operations by coordinating sample management activities, maintaining laboratory inventory, and ensuring compliance with current Good Manufacturing Practices (cGMP).
- This position is responsible for the receipt, preparation, tracking, distribution, shipping, and disposal of raw materials, in-process samples, and drug substance samples.
- The role also provides general laboratory support to ensure efficient and compliant QC operations.
- 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.
Duties and 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.
Required Qualifications:
- 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 Qualifications:
- 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.