Sr. Quality Project Specialist-29345

About the role

This position will work in the Documentation Control Group. Knowledge and experience working with controlled documents, and document control processes is highly preferred.

This position will manage a single large project or several smaller projects. The selected candidate will expedite, manage, implement, and coordinates a multitude of interrelated activities including QA/RA requirements. Supports division Training quality systems and documents practices into internal processes and procedures.

Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for area of expertise. Supports implementation, training and monitoring of projects and programs related to Training and/or Quality Systems to ensure that cGMP requirements are continuously being met. Prepares and presents Training system progress reports to keep management informed.

Anticipates, recognizes and communicates quality issues to the appropriate organization and develops actions to resolve the issues. Prepares and presents written and oral reports and other presentations to internal and external audiences.

Qualifications & Requirements

Bachelor's degree in engineering, scientific or technical area with 3-5 experience in regulations and standards affecting medical devices.

Skill Requirements

• Administrative: Answer telephones, maintain logs/records, organizational skills, proficiency with numbers, research information, time management, use computerized databases, written and verbal communications.
• Machine: Personal computer.

Physical Demands

Speech clarity, utilization of fingers and hands, standing-remaining on one's feet in an upright position, sitting-remaining in the normal seated position, handling-seizing, holding, grasping. Moderate physical effort (up to 30 pounds); must comply with applicable safety procedures.

Working Conditions

Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.

Vision Requirements

• Far acuity-ability to see clearly at 20 feet or more; near acuity-ability to see clearly at 20 inches or less; depth perception-ability to judge distance and space relationships; color vision-ability to distinguish and identify different colors.
• License/Certification/Education: Requires a High School Diploma or equivalent with a minimum of one year of verifiable phlebotomy experience. Normally requires a Valid Driver's License along with a clean driving record.