Quality Specialist Consultant

Responsibilities:

- Perform audit trail reviews for assigned systems (manufacturing or QC lab), ensuring compliance with DI standards.

- Identify and escalate suspicious or non-compliant activities within audit trails.

- Document findings and maintain accurate records of reviews.

- Support the development of documentation including parameter lists, work instructions, and training materials.

- Collaborate with staff to transition systems into the new ATR program.

- Take detailed notes during system familiarization to aid in documentation creation.

Qualifications:

- Experience in either manufacturing (filling and packaging) or QC laboratory environments.

- Strong understanding of Data Integrity principles and regulatory expectations.

- Quality background preferred, with demonstrated ability to assess electronic records for anomalies.

- Prior experience conducting audit trail reviews is highly desirable.

- Excellent documentation and communication skills.

- Ability to work independently and manage priorities effectively.