Missouri: Senior Quality Specialist – Data Integrity (DI) Program Leader (230794)

Life Sciences & Technology | Quality Assurance & Quality Control
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Job Description:

Our client is seeking a Senior Quality Specialist – Data Integrity (DI) Program Leader for a 3-6 month contract. This individual will provide QA Oversight of Data Integrity Program. The Program Leader will implement procedures, training and oversight aligned with PSG policies and global regulations to ensure the integrity of data generated to support manufacturing and testing processes. This role owns the DI Plan and will collaborate across functions to ensure targets are met.

Responsibilities include:

  • Implement DI practices and procedures to meet regulatory requirements.
  • Coordinate routine DI Surveillance, weekly DI awareness topics, and monthly reporting to the site leadership team.
  • Collaborate with cross functional teams for continuous improvement of processes to facilitate right first-time documentation.
  • Facilitate risk assessments for new and existing equipment and systems and provide strategic direction for remediation
  • Develop, own, and update procedures as necessary to ensure clear direction and understanding of data integrity principles and requirements.
  • Support the change control and deviation management processes with respect to potential data integrity impact and ensure appropriate implementation actions are carried out to maintain compliance. 7. Serve as the point person during client and regulatory inspections for DI Education

 

 

Required Experience:

  • Education: Bachelor’s degree in engineering, chemical / biological science or related technical field.
  • Equivalent combinations of education, training, and relevant work experience may be considered Experience
  • At least 7 years experience in the pharmaceutical industry with related technical and quality knowledge including laboratory and manufacturing data integrity. Experience with quality control data, chromatographic systems, laboratory instruments, manufacturing equipment and quality management systems.
  • Prior management experience preferred Knowledge, Skills, Abilities
  • Strong understanding of current Good Manufacturing Practices and application of 21 CFR Part 11 and Annex 11.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
  • Strong interpersonal and presentation skills with focus on influencing and team building
  • Ability to drive functional, technical and operational excellence.

 

 

Missouri: Senior Quality Specialist – Data Integrity (DI) Program Leader (230794)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
Missouri

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