Job Title: Quality Systems Management Specialist

Revision: 0000

Job Code: 703743

Shift: Monday – Friday, 8am-5pm

FLSA: Exempt

Hybrid? Y

CPF Level: TB2

Location: Norcross, GA

Dept.: Global Quality & Compliance (BBG)

Business Unit: BioBridge Global

General Summary

Responsible for the execution of tasks associated with the Quality Management Systems (QMS). Quality Systems Management (QSM) functions include but are not limited to performing assessment of compliance to procedures through document (Record) and procedure review, audits and walkthroughs. Performing investigation of deviations or other quality events related to GxP systems, to ensure appropriate root cause analysis is performed and risk appropriate corrective actions and preventive actions are identified. QSM activities also include performing audits and inspections and ensuring inspection readiness at all times. Assessing requests for change and performing Management of Change (MOC) activities including tracking change deliverables and ensuring completion prior to Change Closure. Ensuring equipment maintenance and calibration records are accurate and complete, and that corresponding qualification activities are reviewed for accuracy and completeness. Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.

Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.

Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

Major Duties and Responsibilities

Essential Tasks

Reviews documentation, including records, procedures, and forms to ensure quality endpoints and compliance requirements are achieved.

Serves as a resource to facilitate Quality Event and CAPA Investigations, Continuous Improvement projects, data analysis, trend identification root cause analysis and development of action plans to support the QMS.

Takes a leading role in the development, implementation and maintenance of Quality System processes required compliance to applicable Standards and Regulations.

Work collaboratively with functional areas to train, guide, and/or facilitate QMS requirements, Continuous Improvement, and Audit Support.

Actively lead and/or contribute to data relevant to Quality Systems Compliance in periodic Management Review meetings.

Assists Quality Management in coordinating and actively participating in Quality or Compliance related projects.

Performs other duties as assigned.

Non‐Essential Tasks

Assist other departments as assigned.

Education

Requires a high school diploma or general equivalency diploma.

Prefer sixty (60) hours from an accredited college or university or Associate Degree from an accredited college or university.

Experience

Requires one or more years of Quality Assurance or Quality Control experience in regulated environment. Prefer two or more years of Quality Assurance or Quality Control experience in regulated environment.

Knowledge

Must acquire a working knowledge of all administrative aspects of document control operations and eQMS.

Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).

Must maintain knowledge of ISO Standards, cGMP (current Good Manufacturing Practices) and regulatory requirements concerning creation and maintenance of controlled documents and record retention.

Skills

Must have strong computer skills.

Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel. Must have excellent telephone and/or email etiquette skills.

Must have excellent written and oral communication skills.

Abilities

Must be able to keep information confidential.

Must be neat in appearance and well groomed.

Must be professional, detail oriented, self‐motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.

Must have the ability to answer telephones and greet the public in a friendly and courteous manner.

Must maintain good working rapport with all departments.