Our client in Cambridge, MA is seeking a Quality Control Analyst III with a strong experience working in with CAPAs, Quality Management Systems, and knowledge of GMP in a lab setting. This is a long term contract with opportunity to extend.
- Responsible for coordinating or contributing to complex projects of moderate scope within QC and cross-functionally.
- Independently manages analytical reference standard programs for commercial drug substances and drug products including qualification /requalification, inventory, supply / shipping.
- Supports analytical test method validation and transfer activities at and between external sites.
- Reviews experimental data generated at contract laboratories.
- Writes, reviews and/or revises controlled documents when necessary.
- Independently applies scientific judgment and contribute to milestones related to specific projects.
- Represents QC business processes and needs within the department and at cross functional forums
RESPONSIBILITIES (INCLUDE BUT LIMITED TO):
- Demonstrates functional versatility and perform work on complex problems of broad scope that encompass multifaceted project and methodological areas.
- Decisions have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.
- Proactively participates in the planning and prioritization of multiple projects and/or the resolution of quality and compliance issues.
- Initiates and owns deviations, CAPAs and change controls within the electronic Quality Management System.
- Proactively revises and authors new SOPs and study documentations.
- Independently executes activities without supervisor guidance.
- Leads and coordinates projects with other departments /vendors.
- Recognized as a technical expert. Demonstrates an understanding of how method performance impacts the business over time.
- May perform other duties as assigned.
- May participate in vendor site visits and audits.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelors or Masters Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience.
- Experience with statistical and data analysis software is beneficial.
- Experience supporting quality and health authority audits is beneficial.
- Experience coordinating international shipments of dangerous materials is beneficial.
- Experience in a GMP laboratory environment is required.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Attention to detail and the ability to work in a fast paced environment is required
- Excellent written and oral communication skills and proficiency in completing written reports, SOP, and protocols
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must display eagerness to learn and continuously improve.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- This is an outward facing position that interfaces heavily with contract laboratories.
Sthree US is acting as an Employment Business in relation to this vacancy.