Sr. Quality Associate I, QA, Final Container Release

Shift: 1st - M-F 8:00am - 4:30pm

Summary:

The Senior Quality Associate I Quality Assurance may be assigned duties and responsibilities within Quality Assurance. Specific duties will depend on the assignment and may include; review of manufacturing or testing records preparation or review of failure investigations sampling/testing/data analysis auditing data analysis for stability etc. The incumbent is an established and technically competent professional who develops and implements solutions to a variety of quality related objectives. He/she may participate on teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise executes assignments of medium complexity developing solutions for defined problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

Primary Responsibilities:

Senior Quality Associate I Quality Assurance

• Consults with management to develop and implement solutions for achieving quality related objectives.
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
• Uses expertise to make independent decisions within defined areas of responsibility.
• Participates on multi-disciplined project teams. Also advances technical project proposals to senior management following through to successful completion.
• Collects and analyzes data
• Prepares and reviews SOP revisions technical reports in DCM and Change Control Requests
• Demonstrated ability to make sound quality decisions with moderate guidance
• Prepares reviews and/or approves Incident Tracking System entries and investigation reports.
• Demonstrates high levels of values and integrity.
• Follows cGMP and department safety practices.
• Other duties as assigned or as specified in the Additional Responsibilities section below may apply.

Additional Responsibilities:

Senior Quality Associate I Quality Assurance

In addition to the duties described above the Sr. Quality Associate I Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned:

Responsibilities may include roles (such as author reviewer administrator or coordinator) in quality systems such as Change Control Discrepancy Management Quarantine Batch Release SAP SAP Quality Module Documentation and Annual Product Reviews as well as provide Quality input for Validation projects capital engineering projects clinical studies stability studies ETPs and Regulatory submissions. Responsible for representing Quality at business unit meetings and project meetings.

Additional responsibilities may include preparation of release protocols and necessary certification for new market registration and license renewal. Support changing market requirements. Maintenance of release certificates of analysis preparation of periodic RA reports tracking batch release status including accepted rejected reprocessed and reworked batches. Managing document revisions in support of change controls projects continuous improvement initiatives etc. Support IT projects related to batch release. Assist with tracking media fills and personnel training within the department.

Knowledge Skills & Abilities:

Senior Quality Associate I Quality Assurance

Excellent communication skills (written and verbal). Has basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.

Knowledge of current products product specifications different market requirements and regulations is addition knowledge of SAP QM is highly preferred.

Requirements:

Senior Quality Associate I Quality Assurance

BS/BA degree preferably in a STEM (Science Technology Engineering and Mathematics) discipline with minimum of 5 years relevant experience or equivalent combination of education and experience.

Occupational Demands:

Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast simple movements of the fingers hands and wrists. Ability to make precise coordinated movements of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks bends and twists neck and waist may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.