Sr. QA Representative

This is a 2nd shift role.The primary responsibility for this role is to provide Quality Assurance oversight to manufacturing operations to ensure that production processing and other activities within the manufacturing areas are meeting cGMP requirements.

Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed.

Performs and documents line clearances and room releases for Manufacturing use.Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented.

Monitors the formulation, filling, inspection, and packaging processes to ensure cGMP compliance, drawing AQL and other samples as appropriate and documenting results and any observations.

Requires qualification for manual visual inspection of parenteral drugs.Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators.

Requires qualification in aseptic gowning and certification as an aseptic processing SME. Documents, reports, and trends observations stemming from Quality Oversight.

Documents and reports to management any AQL failures, GMP violations, unsafe conditions, or other unusual results or practices.

Partners with manufacturing supervision to immediately address and develop plans of action for deficiencies observed in manufacturing operations or the manufacturing facilities.

Deficiencies include any GMP violations, unsafe conditions, or other unusual results or practices. Escalates significant issues immediately to Quality Assurance management.

Performs document revisions, deviation reviews, and processes change controls in existing Quality Systems.Performs special projects and other duties as assigned.

Provides training to operations personnel in areas such as FDA requirements, good documentation practices, contamination prevention, and housekeeping.

Serves as a resource during investigations of non-conformances and unexpected events. This includes interviewing operators and providing first-hand accounts of operations observed.

As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.

Who You AreMinimum Qualifications : A minimum of two years of college is required with a bachelor's degree preferred.Two or more years of related experience in the pharmaceutical industry (preferably in QA)Preferred Qualifications : Requires accuracy, thoroughness, and an attention to detail.

Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometryAbility to read and interpret documents such as quality standards, safety rules, operating and maintenance instructions, and procedure manuals.

Ability to write routine reports and correspondence.Excellent interpersonal and team skills; an ability to work independently and carry out QA decisions based on GMPs and appropriate procedures.

Familiarity with computer software applications including Microsoft Excel, Word and AccessFamiliarity with Quality Management computer systems and SAP a plus.

This role provides the primary quality assurance on-the-floor oversight for manufacturing activities at the facility. There are multiple QA floor support representatives supporting manufacturing so that manufacturing activities on each shift are covered.

Ability to lift and / or move up to 25 pounds.