Quality Assurance Technician 1st Shift
BlueRoot Health•Middletown, CT
•Onsite
About The Position
The QA Technician performs floor-level quality assurance across manufacturing and packaging. This role executes in-process checks, line clearance and material verification, receiving and storage controls, label review, status labeling, and environmental and hygiene monitoring, and initiates quality records such as nonconformances and deviations. QA Technician responsibilities are shared between the Quality Assurance Team.
Requirements
- High school diploma or GED required
- One (1) or more years of experience in Quality Assurance, Quality Control, or manufacturing within a cGMP-regulated environment (dietary supplements, food, or pharmaceuticals) preferred.
- Working knowledge of current Good Manufacturing Practices (cGMP), FDA 21 CFR Part 111, and Good Documentation Practices (GDP).
- Strong attention to detail with the ability to perform in-process inspections, line clearance activities, and accurate documentation.
- Basic proficiency with Microsoft Office, including Excel
- Ability to read, understand, and follow Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and work instructions.
- Ability to work in a manufacturing environment and perform routine inspections while standing and walking throughout the production floor.
Nice To Haves
- associate or bachelor's degree in Biology, Chemistry, Food Science, or a related scientific field preferred.
- experience with electronic Quality Management Systems (eQMS), NetSuite, or similar ERP/QMS platforms is preferred.
Responsibilities
- Logbook inspections
- Preventative maintenance monitoring
- Operation and verification of scales and balances (routine accuracy checks)
- Hygienic zoning monitoring
- Water and air supply testing (potable water, compressed air)
- Monitor gowning and hygiene compliance on the floor
- Perform in-process weight checks and inspections
- Random in-process AQL
- Authorizing bottling to continue runs; verify proper materials are used
- Raw material weighing & blending / dispensing verification
- Equipment cleaning verification and line clearance for each machine
- Internal audit assistance
- Review and approval of incoming product labels
- Receiving and controlled-storage program oversight (conditions, segregation)
- Status labeling of materials (quarantine/hold/release/reject tags)
- Monitor controlled storage conditions; inventory rotation (FEFO) and expiry (pick lists)
- In-process allergen swab testing
- Review service-vendor logs
- Initiate and document nonconformance reports and deviations
- Participate in day-to-day logs and trackers (calibration, PM, EM, complaints, deviations, CAPAs, training)
- Personal hygiene, dress code and visitor control / visitor logs
- Issuing records to bottling
- Inventory adjustments and status changes in NetSuite
- Repacking, relabeling, labeling of unlabeled bottle stock; producing unlabeled stock
- Carry out additional responsibilities as assigned to support departmental and organizational goals
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
