ICQA Inspector I

IPQA Inspector I

Job Description:

• Adherence to all company procedures/SOPs (Standard Operating Procedures)

• Drives, Demonstrates, and Trains personnel on Good Documentation Practices (GDP)/Good Manufacturing Practices (cGMP) in all controlled areas

• Performs finished product inspections on all products using measuring equipment when required, such as but not limited to; calipers, crimp gauges, pressure gauges, and scales.

• Performs and documents required AQL visual inspections as specified in the master batch record Performs real time in-process review of each batch record in its entirety

• Performs real time in-process review of cleaning recordsVerifies pre and post clearance activities during production runs

• Performs daily verification of instrumentation to ensure all calibration is up to date.

• Performs monitoring, verification and review (when applicable) of monthly logbooks (temperature, pressure differential, equipment logs, etc.)

• Accurately reviews and records data in accordance with current FS Data Integrity Policies

• Accurately collects, labels and delivers retain samples, customer samples, analytical and micro labs samples, and stability samples when required

• Performs label issuance and reconciliation activities

• Acts as a liaison between Quality and Production to prevent and/or assist in the resolution of events that occur on the production floor

• Demonstrates proficiency in performing quality finished product inspections on at least 75% of different production machine line

• Provides support to all other departments in an overall quality capacity when needed but not limited to; Operations, Lab, and Warehouse

• Assists IPQA Manager and IPQA Supervisors with Quality Investigations

• Performs annual retain inspection and destruction

• Promotes teamwork, continuous improvement and customer satisfaction

• Participates in other activities as required by Quality Management.

QUALIFICATIONS:

• Working knowledge of FDA regulations for drugs and/or medical devices.

• Knowledge of inspecting critical parameters for following products: aerosols, tubes, liquids

• High School diploma or equivalent. CRITICAL SKILLS AND ABILITIES:

• Ability to use a personal computer and measuring devices.

• Attentive to detail, thorough and accurate

• Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.

• Ability to perform effectively under conditions of fluctuating workload.

• Ability to handle and resolve recurring problems.

• Communicate with others clearly and concisely.

• Ability to work in a fast-paced environment sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.