Description

Job Purpose

✓Perform Quality Attributes and Visual Inspection of drug product through the packaging process including Visual Inspection in compliance with company policies / procedures, FDA and cGMP regulations.
✓Ensures the accuracy and completeness of manual and electronic batch records.
✓Assists with additional work duties or responsibilities as evident or required.

Essential Duties and Responsibilities

✓Monitors and performs visual inspections and finished product inspections.
✓Perform visual inspections of Outsourcing products.
✓Monitor all packaging areas and personnel for adherence to all cGMP, SOP’s and safety regulations.
✓Keep line and work station clean and orderly to ensure no product line contamination.
✓Perform line clearance including equipment, components and label verification.
✓Support validation and manufacturing studies including special sampling and testing.
✓Organize workload during lot changeovers for efficient execution.
✓Release finished product for packaging after visual inspection.
✓Review all completed batch record documentation to ensure completion and compliance with Good Documentation Practices.
✓Perform QA functions for Accraply, HP, and Autoclave processes.
✓Cross-train in other department(s) to expand job knowledge.

Shop Floor QA Accountabilities

✓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.

✓Detail oriented.
✓Good computer skills in MS Outlook, MS Word, and MS Excel
✓Good visual acuity and observation skills.
✓Good written, oral and comprehensive communication skills.
✓Ability to handle diversity of projects.
✓Specific expertise, skills and knowledge within quality assurance gained through education and experience.
✓Ability and willingness to change direction and focus to meet shifting organizational and business demands.
✓Ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

✓High School Diploma or GED
✓Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred.

✓Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), vision (20/20), standing (40%), sitting (40%), walking (20%), typing, and hearing.