Quality Operations Visual Inspector - Tier I

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.