Quality Operations Visual Inspector - Tier I

Description

Job Purpose:

Perform visual inspection of injectable products in compliance with company policies/procedures, FDA and cGMP regulations

Maintains quality assurance documentation by ensuring the accuracy and completeness of batch records.

Promotes teamwork both within the QA Team and other departments.

Monitor all packaging areas and personnel for adherence to all cGMP, SOP's and safety regulations.

Keep line and work station clean and orderly.

Perform line clearance including equipment, components and label verification.

Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor.

Specific expertise, skills and knowledge within quality assurance gained through education and experience.

The ability and willingness to change direction and focus to meet shifting organizational and business demands.

Able to handle diversity of projects.

The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

Essential Duties and Responsibilities:

Monitors and performs finished product attribute inspections.

Performs visual inspections of Outsourcing products if deemed necessary or required.

Supports secondary packaging operations by performing QA verifications of packaging, label verifications, etc.

Maintains quality documentation and review to ensure completion and compliance.

Promotes teamwork both within the QA Team and other departments.

Keep line and work station clean and orderly.

Ensure that there is no cross contamination.

Perform line clearances.

Support validation and manufacturing studies including special sampling and testing.

Organize workload during lot changeovers for efficient execution.

Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.

Assist with development of solutions for chronic problems within quality assurance

Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.

Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.

Assist in other activities (as needed) for Quality Assurance management.

Supplemental Functions:

• •Copying, filing, and scanning of documents.
• •Performs other similar duties as required.
• •Assist in other activities (as needed) for Quality Assurance management

Knowledge & Skills:

Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred.

Good written, oral and comprehensive communication skills.

Strong understanding of document control procedures, standards, and best practices

Detail oriented.

Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills.

Good visual acuity and observation skills.

Good written, oral and comprehensive communication skills.

Able to handle diversity of projects.

Specific expertise, skills and knowledge within quality assurance gained through education and experience.

A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

The ability and willingness to change direction and focus to meet shifting organizational and business demands.

The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.

Requirements

Job Specifications and Qualifications:

Visual Inspection certification

Education/Experience:

• •1-3 years of related experience in the pharmaceutical industry.
• •High School Diploma or GED

Working Conditions / Physical Requirements:

This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.