**Quality Control Compliance Specialist**
Purpose:
The Quality Control Projects Team is responsible for the introduction of new equipment and lifecycle equipment management, including software updates. The team drives ongoing quality control continuous improvement initiatives.
Responsibilities:
1. Generate documentation, including URS writing, GxP assessments, SOPs/WIs.
2. Review and approve documentation: IOQ, PQ, SOP, etc.
3. Upgrade and introduce instruments in the QC laboratory, ensuring timely implementation to support product testing and meet manufacturing deliverables.
4. Participate in Change Control Request facilitation and management regarding QC instrument introduction.
5. Oversee the introduction of instruments for the QC laboratory.
6. Collaborate with the Project Manager to ensure project timelines and critical milestones are met during new instrument introductions.
7. Work with Validation, QA, IT, Metrology, QC Analyst, SME, and DI teams for qualification & validation strategy alignment, timely completion of the GxP assessment, User Requirement Specification, IOQ protocol pre-approvals, and associated documentation.
8. Conduct duties in a safe manner and report all safety issues or concerns.
9. Ensure all required training is completed on time.
Qualifications:
1. One to two years' experience in a similar compliance or projects role (preferable).
2. Third-level qualification (degree in science or related discipline) or relevant experience supplementing a lower-grade scientific qualification.
3. Excellent communication skills (interpersonal, presentation, and writing).
4. Ability to work well with others at all levels of the organization, across multiple sites, and in a multinational environment.
5. Initiative – able to work independently to see issues through to completion.
**Key Skills:**
* Documentation generation and review.
* Instrument upgrade and introduction.
* Change control request facilitation.
* Qualification and validation strategy alignment.
* Safety and compliance awareness.
**What We're Looking For:**
* A motivated individual with a passion for quality control and compliance.
* Excellent communication and interpersonal skills.
* Able to work independently and as part of a team.
* Strong problem-solving and initiative skills.