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Job ID :
62126BR
Location :
US - Puerto Rico - Manati
:
Job Description

GLOBAL JOB DESCRIPTION

Job Title: Data Integrity Compliance Officer

Effective Date / Last Modification Date: 15OCT2015

Summary:

Ensures laboratories are in compliance with industry regulations, corporate data integrity standards, documentation practices and procedures as related to both paper and electronic records. Leads a team to ensure quality data reporting for the department and site.

Essential Functions:

Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed; meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry standards. Establishes operational objectives and assists with developing, modifying and executing company policies.

Ensures all new and existing equipment is assessed appropriately and validated for its intended use and existence. Coordinates procedure/process testing and provides reviews of audit trails.

Provides gap assessments and status updates to senior management to maintain and improve data integrity.

Performs risk assessments to determine high risk equipment and determines appropriate corrective action.

Leads departmental data integrity training for all lab / production operations, ensuring awareness and compliance with data integrity for both paper and electronic records. Ensures appropriate inspector interactions and good documentation practices.

Develops, manages, and updates procedures as necessary to ensure there is clear direction and understanding regarding awareness, responsibilities and the importance of corporate and regulatory requirements for data integrity compliance.

Creates and executes change controls and establishes user requirements for laboratory and operations equipment.

Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.

Leads and establishes, where necessary, a surveillance program to audit all laboratory and operational practices and staff for compliance with established documentation and data integrity standards, practices and procedures.

Job Scope:

Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.

Supervision:

Manages the coordination of the activities of a section or department with responsibility for results.

Education:

Bachelor’s Degree in chemical or biological sciences or related field.

Experience:

Seven years experience in a regulated industry or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems. Experience with laboratory metrology and instrumentation compliance. Project Management and/or prior management experience preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Strong knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP). Expert knowledge of laboratory instrumentation and/or operations equipment. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously. Ability to drive functional, technical and operational excellence. Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.

SPECIFIC ROLE EXPECTATIONS FOR: Data Integrity Officer

  • Establishes and chairs the Data Integrity Governance Team meetings.
  • Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.
  • Provides assessments and status updates to aid Data Integrity Governance team’s actions to maintain and proactively improve data integrity.
  • Ensures Governance Team deliverables are on target, properly resourced and executed as committed.
  • Communicates actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality
  • Performs risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance. Source and assess and recommend instrumentation/equipment for purchase.
  • Provides quarterly training to all lab operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices.
  • Creates/updates procedures as necessary to ensure lab operations awareness and importance of regulatory requirements and expectations. Evaluate regulatory inspection documents on a monthly basis and keep the Governance Team aware of trends.
  • Meets with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance.
  • Establishes and leads a Surveillance program to audit for compliance to establish documentation and data integrity standards, practices and procedures.
  • Assesses technical responses to questions/issues raised by regulatory agencies and customers. Serves as an advisor to the Site for Data Integrity matters.
  • Represents the company as a subject matter expert during regulatory and customer audits for Data Integrity.
  • Collaborates on projects to meet customer, business, and regulatory requirements.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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