Duties:

Performs sampling/testing/inspection of raw materials, conducts lab investigations, and reports aberrant results to management. Includes, not limited to:
Pulling and aliquoting raw material samples and distributing to the appropriate laboratories.
Prepares paperwork, ships samples, and follows-up with appropriate testing laboratories.
AQL inspection (e.g., visual, dimension, etc)
On call/weekend/swing shift coverage for urgent samples.
Data entry and reviews QC documentation (e.g., test results, data packets, etc.)
Generates, reviews and/or maintains records or documents in a detailed and consistent manner (e.g., sample summary form, test records, etc.).
Reconciles samples. Perform required reviews of appropriate forms (e.g., test records) and logbooks.
Performs an Owner role for Change Controls and Deviations
Prepares and reviews trend reports, generate metrics and other reports as needed. Maintains raw material data.
Revises SOPs, training doc, etc.
Ensures equipment calibration and preventive maintenance are up-to-date
Performs an Owner role for Change Controls and Deviations.

Skills:

In depth experience in a laboratory environment
Five (5) years cGMP or appropriate experience required.
Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards desired.
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