Quality Assurance Technician (1-3)
Department: Quality Department
Reports to: Quality Assurance Manager
1.0 JOB SUMMARY
The Quality Assurance (QA) Technician (1-3) plays a pivotal role in ensuring product quality, regulatory compliance, and safety standards. Their responsibilities include conducting physical and analytical tests on incoming materials, bulk batch blends, reviewing batch records, performing microbial testing, monitoring environmental conditions, and adhering to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMPs).
2.0 ESSENTIAL JOB FUNCTIONS
QA TECH Level 1: (Incoming Focus)
- Accurately and consistently follow Standard Operating Procedures (SOP), Inspection Procedures, Test Methods, and verbal instructions.
- Maintain accurate written records.
- Perform incoming GMP raw material sampling, testing, and approval.
- Scan raw material Safety Data Sheets (SDS) and save them to the SharePoint site.
- Scan Certificates of Analysis (COAs) for incoming raw materials and save them to the lab drive.
- Help maintain lab cleanliness.
- Cross train to learn and support the other QA Tech roles.
- Other duties as assigned.
QA TECH Level 2: (Bench Focus)
- All of QA Tech Level 1
- Test and release bulk batch blends promptly for production.
- Determine bulk batch adjustments (e.g., viscosity, clarity).
- Track batch adjustments using a spreadsheet in the lab drive.
- Maintain bulk batch retention samples.
- Daily calibration of pH meters.
- Maintain temperature log data for lab equipment and manufacturing raw material storage.
- Daily and Weekly water and wastewater analysis
QA TECH Level 3: (Micro Focus)
- All of QA Tech Levels 1 & 2
- Conduct Microbiological testing on GMP products.
- Maintain the microbiological testing supply inventory.
- Perform and maintain product Label approvals and Master copy records.
- Perform gluten testing.
- Daily and Weekly scale calibration verification.
- Perform product analysis on competitive products and benchmark samples.
- Retain samples of finished products and maintain retention sample records.
- Perform sanitization inspection verifications using an ATP luminometer.
- Perform swabbing activities as part of the Environmental Monitoring Program.
- Review production batch records for compliance and completion prior to product release.
- Enter testing data and release product in the ERP system.
- Create Certificates of Analysis (COAs) for finished goods.
- Assist with high-priority projects as needed.
- Perform non-conforming material investigations as needed.
- Perform calibration verification activities.
- Review SOPs and update them as needed to reflect current production practices.
- Perform internal inspections and communicate any non-conformances with management.
3.0 SKILLS
- Experience following detailed procedures and maintaining accurate records.
- Strong math and analytical skills.
- Excellent communication and writing skills.
- Ability to lift up to 60lbs.
- Experience with standard wet lab equipment and methods including pH meters, pycnometers, balances, titrations, etc.
- Experience with standard computer software such as Microsoft Office applications.
4.0 Necessary Education and Experience
- Postsecondary coursework in Chemistry, Biology, or related technical field OR
- Two years manufacturing quality, laboratory experience, or equivalent.
- Microbiology and/or QC/QA experience is preferred.
- Experience working in a GMP environment and familiarity with GMP requirements.
Average salary estimate
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