QC Associate IV

Duties

Reviews raw material lot packages and releases RM lots for GMP manufacturing use.

Ensures lot release timelines will be met and coordinates testing performed at in-house and contract laboratories. 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.

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.

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

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.) Performs logbook and/or LIMS entries when using equipment/instruments. Reconciles samples. Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks.

Assists with QC's data management, including data review and trending.

Maintains specific QC files and database records for process and/or quality improvement efforts.

Maintain laboratory cleanliness and orderliness.

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

Skills

Skills : 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.

Knowledge of SAP, Trackwise and LIMS desired.

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