Duties: Performs tasks and activities related to supplier/material qualifications and supplier change notifications (e.g., review of vendor documentation, review of vendor and material history, etc.)

Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, material specifications, analytical investigations, and laboratory test plans and related technical reports. Ensure compliance with current regulations.

Supports lot release activities. This includes, but not limited to, preparation of sample submission forms, performing necessary LIMS and SAP transactions, review of test records, tracking status of samples and their respective tests, etc.

Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.

Maintain laboratory cleanliness and orderliness.

Cross-train in other RM duties to cover for other RM members when needed.

Skills: In depth experience in a laboratory environment - Six (6) years cGMP or appropriate experience required.

Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards required.

Strong technical writing required

Knowledge of CFR, USP, and ICH required.

Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet time lines.

Demonstrated problem-detection and problem-resolution skills required

Physical Demands / Surroundings:

Lifting, carrying, pushing or pulling up to 50 pounds occasionally Frequent periods of sitting, walking, and standing Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat Occasional low level work, fine finger dexterity/ including grasping or pinching required Writing and use of a computer keyboard frequently Occasional use of personal protective equipment

Keywords:

Education: Bachelors’ degree in a Scientific Discipline.

Salary Range - 45,000K-50,000K