View Our Website View All Jobs

Data Integrity Compliance Officer

Currently seeking a Data Integrity Compliance Officer
The Data Integrity Compliance Officer 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.

KEY RESPONSIBILITIES

  • 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.

QUALITIFICATIONS

  • Bachelor’s Degree in chemical or biological sciences or related field
  • 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.
  • Equivalent combinations of education, training, and relevant work experience may be considered.
Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file

150