QC Laboratory Technician (Entry Level) – GMP Pharmaceutical Contract Manufacturing
About the Role
We’re seeking an entry‑level Laboratory Technician to support our Quality and Compliance operations within a GMP contract manufacturing environment. This role is ideal for early‑career candidates who are detail‑oriented, process‑driven, and comfortable working within regulated systems. You’ll help ensure raw materials and controlled environments meet stringent quality standards by coordinating sampling and testing, maintaining compliant data and documentation, and supporting day‑to‑day lab activities—including basic wet chemistry and other laboratory support.
Key Responsibilities
GMP Raw Materials – Compliance, Sampling & Testing Coordination
- Order, receive, and log incoming GMP raw materials; verify supplier documentation (CoA, SDS, compendial references) and specifications against approved standards.
- Execute sampling plans (per SOPs) for raw materials: collect, label, and manage samples, including retains and stability/retest samples.
- Coordinate internal and 3rd‑party laboratory testing (chain‑of‑custody, sample shipment, test requests, turnaround tracking, and results reconciliation).
- Data entry and status tracking e.g., material release status, quarantines, holds
- Organize and maintain material records: specifications, change controls, deviations, OOS/OOT tracking, and CAPA follow‑ups (under guidance).
Controlled Storage Areas – Monitoring, Trending & Compliance
- Perform routine monitoring of controlled temperature/humidity storage (raw materials, intermediates, retains).
- Download, review, and trend environmental and storage data; escalate alarms/excursions per SOPs.
- Calibrate/verify monitoring devices (with supervision) and maintain calibration records.
- Support investigations for excursions: gather data, document timelines, and contribute to root‑cause assessments.
Basic Wet Chemistry & Lab Support
- Perform entry‑level wet chemistry (pH, conductivity, osmolality, titration, moisture/LOD, specific gravity) under SOPs and training.
- Prepare solutions, reagents, and standards; maintain chemical inventory and proper storage/labels.
- Operate and maintain routine equipment (balances, pH meters, conductivity meters, incubators); complete use logs and verification checks.
Documentation, Data Integrity & Compliance
- Follow GMP/GDP (good documentation practices) in all records (paper/electronic).
- Draft/complete forms, checklists, logbooks, and test requests accurately and timely.
- Support deviations, change controls, OOS/OOT, and CAPA documentation (as directed).
- Participate in SOP training and adhere strictly to safety, EHS, and compliance policies.
Qualifications
Required
- AS or BS in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field.
- 1–2 years in a lab, manufacturing, or quality environment (internships and co‑ops welcome).
- Familiarity with GMP concepts and GDP documentation standards.
- Comfort with data entry, Excel-based trending, and basic lab equipment.
- Strong attention to detail, organization, and time management.
- Ability to lift up to ~30 lbs, stand for extended periods, and work in controlled environments with PPE.
Preferred
- Experience in pharma/biotech (CMO/CDMO) or regulated industry.
- Basic understanding of USP/EP compendial methods, ICH Q7/Q9/Q10 concepts, and 21 CFR Parts 210/211 terminology (training provided).
- Familiarity with quality systems: deviations, CAPA, change control, and OOS/OOT workflows.
Core Competencies
- Compliance & Integrity: Follows SOPs, maintains data integrity (ALCOA+), escalates issues promptly.
- Detail Orientation: Accurate labeling, documentation, and sample handling.
- Ownership & Reliability: Meets schedules for sampling, monitoring, and reporting.
- Communication: Clear updates to QA/QC, Supply Chain, and external labs.
- Continuous Improvement: Identifies small process improvements, supports 5S in lab/storage areas.
Work Environment & Schedule
- On‑site laboratory and controlled storage areas; routine use of PPE (lab coat, gloves, safety glasses; additional PPE as needed).
- Day shift
- Collaborative cross‑functional work with QA, QC, Warehouse, and external labs.
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