Quality Operations Visual Inspector - Tier I

Essential Duties and Responsibilities

• Maintains quality assurance documentation by ensuring the accuracy and completeness of batch records.
• Promotes teamwork both within the QA Team and other departments.
• Maintain cleanliness and orderliness of line and work stations.
• Performs line clearance including equipment, components, and label verification.
• Communicates quality-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the Supervisor.
• Supports secondary packaging operations by performing QA verifications of packaging, label verifications, etc.
• Maintains quality documentation and review to ensure completion and compliance.
• Ensures no cross-contamination occurs.
• Supports validation and manufacturing studies including special sampling and testing.
• Organizes workload during lot changeovers for efficient execution.
• Maintains adherence to cGMPs by staying informed of current FDA requirements and ensuring compliance through familiarization with relevant Standard Operating Procedures (SOPs).
• Assists with monitoring all production areas and personnel for adherence to cGMPs, SOPs, and safety regulations.
• Assists in development of solutions for chronic problems within quality assurance.
• Communicates quality-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to Quality Management.

Supplemental Functions

• Copying, filing, and scanning of documents.
• Performs other similar duties as required.

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.
• Able to handle diversity of projects.
• 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.
• The ability to create and contribute an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback, and recognition.
• The ability to effectively manage oneself, demonstrate integrity, be productive under pressure, and achieve development goals.

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 lbs.), standing, sitting, and walking throughout the facility.