Quality Systems Specialist II for Data Integrity

4 weeks ago

US Petersburg VA USA Civica Rx Full time

About Civica

Civica is a 501(c)(4) social welfare organization established to reduce chronic generic drug shortages and related high prices in the United States. The organization is led by an experienced team of healthcare and pharmaceutical industry leaders.

Civica has formed a team at the Petersburg, Virginia site to oversee the manufacture and supply of essential generic sterile injectable medications. The team is responsible for ensuring the quality and integrity of the data used in the production process.

The Quality Systems Specialist II for Data Integrity will play a critical role in this team, overseeing the data governance program and ensuring that appropriate data integrity controls are in place to protect data throughout the data lifecycle.

Responsibilities of the position include:

  • Maintaining the data governance program, including design, operation support, and monitoring.
  • Providing mentorship and advice on approved procedures, standardization, and requirements associated with the quality management system (QMS) and data integrity.
  • Leading data integrity investigations and working cross-functionally to determine root cause and CAPAs.
  • Supporting audit trail reviews and analyzing metrics to measure the effectiveness of the data governance program.
  • Subject Matter Expert and Key User supporting data integrity and good documentation practices (GDocP).
  • Identifying and raising data integrity compliance gaps across the quality system.
  • Developing and delivering training to new staff on data integrity and other processes and procedures.
  • Supporting audits (internal, regulatory) and inspection readiness activities.
  • Promoting a culture of quality and driving enthusiasm for data integrity compliance.
  • Executing critical initiatives to improve the quality system and data integrity.

Basic Qualifications and Capabilities:

  • Bachelor's degree with 6+ years of combined technical experience in a GMP related field within a pharmaceutical/biologics manufacturing facility.
  • Experience with Quality systems and demonstrated working knowledge in areas such as data integrity, change control, deviation, CAPA, Management Review.
  • Demonstrated experience leading and writing investigations.
  • Ability to lead risk assessments and root cause analysis.
  • Experience with cGMPs and Quality System regulatory requirements.
  • Experience with Quality computerized system applications (e.g., Veeva)
  • Works on multiple assignments in collaboration with various department system owners.
  • Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Strong organization, and execution skills with an attention to detail.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills and share knowledge with others. Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

Civica is a dynamic and innovative organization that is committed to ensuring the quality and integrity of the data used in the production process. If you are a motivated and experienced professional who is passionate about quality and data integrity, we encourage you to apply for this exciting opportunity.

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