QA - Compliance Investigator
Scope of Position
This role is responsible for conducting investigations and preparing investigation reports for review by customers and health authorities.
Responsibilities
- Coordinates investigation team meetings and activities to facilitate the timely closure of investigations.
- Coordinates Improvement initiatives monitors the progress of deliverables and provides support.
- Facilitates QA support and works closely with other functional units including but not limited to, Manufacturing, Validation, Facilities Engineering, Pre-Clinical, Analytical Development, Quality Control, and Global Compliance for designated projects and activities.
- Interface with clients and Health Authority representatives during investigations and CAPA discussions
- Prepares and routes investigation reports in TrackWise.
Skills & Technical Expertise:
- Proficient in TrackWise
- In-depth knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, the USP, ICH Guidelines, and industry best practices. EU GMPs a plus.
- Knowledgeable and/or exposure to GMP operations, quality system management and quality control testing, etc. especially in the manufacturing of sterile solutions and solid oral dose products
- Ability to quickly learn new and novel processes supporting new quality projects
- Ability to self-direct, and adapt to changing priorities
- Excellent communication and interpersonal skills required
- Strong attention to detail and organization skills required
- Proven technical writing and editing skills
- Root Cause Analysis skills
- Creative individual with excellent problem-solving and troubleshooting skills
- Requires the ability to produce results in a fast-paced environment
- Leadership capabilities
- Project management capabilities
- Facilitator training and capabilities
- Special Skills – influencing, interpersonal, ability to stand alone and dealing with ambiguity
- Proficiency with electronic management systems (such as Master Control and TrackWise)
- Experience with MS Office applications and Adobe Acrobat
Supervision
- Work independently under general supervision to meet company goals
- Experience leading cross-functional teams
Qualifications
- B.S. in a Life Sciences discipline– OR – M.S. in a Life Sciences discipline
- 5+ years of relevant experience within the life sciences industry, preferably CDMO Manufacturing of pharmaceuticals, performing within a Quality Assurance role