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.