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.