Senior Associate - Contract - Waltham, MA
Keep quality on track and inspection‑ready by owning the systems that keep operations running smoothly.
Proclinical is seeking a Senior Associate, Quality Systems for a contract role based in Waltham, MA. This role requires a hands-on approach to improve and maintain quality systems while supporting day-to-day operations.
Primary Responsibilities:
The successful candidate will support cross-functional GXP activities related to Quality Systems, ensuring compliance with current Good Manufacturing Practices (cGMP) and maintaining inspection readiness.
Skills & Requirements:
- Strong time management and organizational skills, with the ability to prioritize and manage multiple tasks effectively.
- Ability to work independently with minimal supervision.
- Proactive problem-solving skills with a diplomatic and flexible approach.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Access, and Outlook).
- Excellent written and verbal communication skills.
- Ethical, self-motivated, and detail-oriented.
- Bachelor's degree or equivalent experience in a regulated manufacturing environment.
- Practical experience in a regulated environment, with a minimum of 4 years of relevant experience.
The Senior Associate's responsibilities will be:
- Provide on-site support for the Quality Systems department, working onsite five days per week.
- File, archive, and manage documentation, including validation binders, assay packets, training documents, and miscellaneous paperwork.
- Create and issue logbooks.
- Issue batch records for Manufacturing and Supply Chain teams.
- Review records and documents for completeness and accuracy.
- Organize and inventory paper records, prepare them for offsite archiving, and maintain the document control room.
- Support the document lifecycle within the Electronic Document Management System (EDMS), specifically MasterControl.
- Assist the Director of Quality Systems with various projects and preparation of metrics.
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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