Job Description Summary

The Manufacturing Quality Inspector, MQI, has basic responsibility for monitoring the quality system within the in-process manufacturing of the Low Volume production suite. Ensures the documentation process and cleanroom elements remain compliant.

The role provides guidance for the various elements of the Quality System, for example, to ensure process control, identifies/recommends opportunities for continuous improvement (internal/external). Limited or Basic application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity.


Responsibilities include monitoring and trending quality indicators for in-process production as well as basic cleanroom activity. Developing solutions to routine problems of limited scope.  Assessing Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow.


Responsible for the various aspects of Media production in maintaining quality focus at all phases of the manufacturing process. Reporting directly to the Quality Engineer, will take daily direction from the Manufacturing Supervisor. Directly responsible for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal audits

Job Description

Responsibilities and Duties

• The role provides guidance for the various elements of the Quality System, for example, to ensure process controls and identifies/recommends opportunities for continuous improvement.
• Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.
• Supports implementation of corrective actions and improvements
• Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes.
• Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures.
• Regular reporting to management the current status of product quality with respect to Quality objectives and goals
• Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP)
• Must follow all BD housekeeping policies and procedures
• Must follow all BD safety policies and procedures
• Must be able to work overtime as required to meet BD business requirements
• Perform other duties as required

Qualifications

Education

• BS in any scientific related discipline
• Associate’s degree with 1 year manufacturing experience in Food, Pharma and Industrial production settings. 
• High school diploma with 6 years manufacturing experience in Food, Pharma and Industrial production settings. 
• Must have experience working in a regulated environment.

Qualifications

• Must complete and maintain gown room certification. Yearly re-certification will be an ongoing requirement.
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
• Limited knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003

Skills

• Ability and skill to effectively manage multiple tasks
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, groups/teams
• Ability to listen to others; including associates, managers, peers when making decisions and solving problems
• Limited knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003

Shift: 4:00 PM - 4:00 AM work schedule 2/2/3

“Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.”

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

US BD 12 Hour day Shift 5pm-530am (United States of America)