Deviations Investigator

Be better. Live Better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives Independently responsible for the efficient and thorough investigation of process deviations, determination of root cause, and initiation of corrective/preventative actions (CAPA) designed to adequately address and correct the deficiencies identified during the investigation process. Responsible for providing proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, impact to product. Responsible for assisting with process change controls. The position requires working with mínimal supervision to manage assigned tasks from initiation to completion.

**RESPONSIBILITIES**:

- As part of each investigation, gathers information from all necessary internal and external sources evaluate the root cause of the deviation and impact on all manufactured product, as well as risk to future operations.
- Works independently to comply with procedure driven guidelines relating to Deviation and Change Control management.
- Ensures that deadlines are met and closely monitors the need for extensions to maintain compliance to site and industry standards.
- Management of multiple investigations concurrently.
- Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems and properly assess risk/impact.
- Updates SOPs and/or Manufacturing Batch Records (MBRs), as required, based on CAPA and continuous improvement needs.
- Assists with initiation and completion of change controls, including development of change plan, completion of impact assessment, and management of change.
- Perform any other tasks/duties as assigned by Manufacturing Management.

**QUALIFICATIONS**:

- BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
- Related pharmaceutical experience required, including relevant experience in manufacturing in a GMP environment.
- Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required.
- Prior experience in Manufacturing Environment or troubleshooting Manufacturing related issues preferred.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Good deductive and inductive critical thinking skills with attention to detail and ability to manage multiple projects with shifting priorities.
- Excellent verbal and written communication skills with advanced writing skills.
- Excellent interpersonal skill and ability to work well on a team.

**Job Type**: Fixed term contract
Contract length: 12 months

Work Location: In person