Description

Position Summary:

• Monitors filling operations in compliance with company policies/procedures, FDA and cGMP regulations.
• Ensures the accuracy and completeness of batch records.
• Performs personnel monitoring, general operations filling in manual hoods, and other duties as necessary.
• Assists with additional work duties or responsibilities as evident or required.
• Primary Accountabilities:
• NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.
• Monitors aseptic techniques of personnel within the clean room.
• Monitor Outsourcing filling operations within the clean rooms.
• Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed.
• Maintains quality assurance documentation.
• Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records.
• Promotes teamwork both within the QA Team and other departments.
• Monitors all filling areas and personnel for adherence to all cGMP, SOP’s and safety regulations.
• Keep line and workstation clean and orderly to ensure no product line contamination.
• Perform line clearance including equipment, components and label verification.
• Perform room releases for filling rooms for Outsourcing areas.
• Communicate quality – related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management.
• Review all completed production batch record documentation to ensure completion and compliance.
• Reviewing Logbooks for GDP and accuracy.
• Performs general operation QA functions for manual filling processes.
• Ability to perform personnel monitoring within the clean room.
• Trained and authorized to enter samples into LabVantage.

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.

Requirements

Knowledge, Skills & Abilities:

• 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.
• 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 board 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 oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
• Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing and hearing.
• Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.