About this role
Duties & Responsibilities
- Develop and manage system lifecycle documentation consisting of User Requirements (URS), Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Traceability Matrix, Qualification Summary Reports, Change Control, and Risk Assessments.
- Assist with the generation and maintenance of SOPs and supporting documents.
- Work with cross-functional teams to troubleshoot equipment, process, and validation issues.
- Perform job responsibilities in compliance with applicable GMP regulations and guidelines as applied to the fields of Systems Qualification, Cleaning, and Process Validation.
- Ensure equipment is released for GMP use within agreed-upon timelines following qualification and cleaning activities.
- Perform investigations, CAPAs, change requests, and engineering projects.
Required Skills & Abilities
- Must have a broad knowledge of Pharmaceutical GMP, along with FDA and international regulations.
- General understanding of change control, CAPA programs, investigation and root cause analysis, and good documentation practices.
- Excellent verbal and written communication skills.
- Excellent interpersonal and collaborative teamwork skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Proven project management skills while working independently.
- Ability to prioritize tasks and to delegate them when appropriate.
- Ability to function well in a high-paced and at times stressful environment.
- Proficient with Microsoft Office Suite or related software.
Education & Experience
- Minimum of a bachelor’s degree, preferably in a scientific discipline. Equivalent experience may be considered in lieu of degree.
- 0-2 years previous GMP experience with background in the Pharmaceutical, Biotech, Chemical, Validation, or QA industry.
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift 15 pounds at times.
- Adheres to consistent and predictable in-person attendance