Job Title: Quality Control Technician I
Department: Quality Control
Position Summary:
The Quality Control Technician I is responsible for supporting the daily operations of the Quality Control laboratory through raw material sampling and testing, routine laboratory analysis, stability program activities, environmental monitoring, and laboratory documentation. This position helps ensure compliance with cGMP, company SOPs, and regulatory requirements while maintaining accurate records and supporting the release of quality products.
Key Responsibilities:
Raw Material Sampling & Testing
· Perform sampling of incoming raw materials in accordance with SOPs and cGMP requirements.
· Perform routine quality testing of raw materials using approved analytical methods as assigned.
· Prepare reagents, standards, and laboratory solutions as needed.
Stability Program
· Track and perform scheduled stability sample pulls in accordance with approved stability protocols.
· Conduct routine stability testing, including appearance, color, odor, pH, weight loss, packaging integrity, and other assigned physical and chemical evaluations.
· Accurately record, review, and organize stability test results in laboratory records and electronic systems.
· Coordinate shipment of stability samples to external laboratories and monitor testing status.
· Assist with maintaining stability inventories, sample storage, and stability schedules to ensure testing is completed on time.
Environmental Monitoring (EM)
- Perform viable and non-viable environmental monitoring of manufacturing and laboratory areas.
- Collect, document, and submit environmental monitoring samples to external laboratories.
- Trend environmental monitoring data and notify management of abnormal or out-of-limit results.
Laboratory Operations & Documentation
· Maintain accurate laboratory notebooks, logbooks, and electronic records in accordance with data integrity principles.
· Perform routine audit trail review as assigned.
· Trend laboratory and quality data to identify patterns, support investigations, and monitor product and process performance.
· Prepare and issue Certificates of Analysis (COAs) for finished products as assigned.
· Assist with data review and other laboratory documentation activities.
Qualifications:
- Education or Experience: Associate or Bachelor’s degree in Chemistry, Biology, Microbiology, or related field. Or 1–3 years’ experience in a QC within an OTC, pharmaceutical, or cosmetic manufacturing environment preferred.
- Skills:
o Knowledge of cGMP and laboratory documentation requirements.
o Strong organizational skills and attention to detail.
o Ability to accurately follow SOPs and perform laboratory procedures.
o Effective verbal and written communication skills.
o Ability to work independently and collaboratively in a team environment.
o Proficiency in Microsoft Office applications.
Additional Requirements:
- Ability to stand for extended periods and handle laboratory equipment.
- Lift up to 25 lbs. for sampling activities.
- Proficiency in English is required; Spanish language skills are a plus.
Pay: From $20.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
