Analyst IV, Quality Control Technical Services - Contract - Boston, MA
Join a cutting-edge pharmaceutical team where your precision and passion for quality analysis will help shape the future of life-saving medicines!
Proclinical is seeking an Analyst IV for Quality Control Technical Services to support quality and compliance efforts from development through commercialization.
Primary Responsibilities:
This role involves contributing to stability studies, data trending, investigations, and facilitating method transfers. The position plays a key part in ensuring the efficiency and effectiveness of QC functions while maintaining regulatory compliance.
Skills & Requirements:
- Background in chemistry, biology, biochemistry, or a related scientific field.
- Experience in a GMP Quality Control function within the pharmaceutical or biotech industry.
- Proficiency in technical specification development, method transfer, and/or analytical method implementation.
- Strong data analysis skills with attention to detail.
- Problem-solving expertise, including conducting investigations and implementing CAPAs.
- Excellent organizational skills and ability to manage multiple tasks independently.
- Effective communication and teamwork abilities in a collaborative environment.
- Familiarity with LabWare LIMS, Excel, Word, and PowerPoint is preferred.
The Analyst's responsibilities will be:
- Support the development and justification of technical specifications for raw materials, intermediates, and finished products.
- Facilitate the transfer and implementation of analytical methods, including validation and training of laboratory personnel.
- Execute and document stability studies to determine product shelf life and ensure regulatory compliance.
- Analyze and trend QC data to identify and address potential quality issues using statistical tools.
- Investigate quality deviations, perform root cause analysis, and implement corrective and preventive actions (CAPAs).
- Review routine and non-routine QC testing to ensure accuracy and reliability of results.
- Prepare and review technical documentation for regulatory submissions and audits.
- Participate in continuous improvement initiatives to enhance QC processes and laboratory efficiency.
- Represent Quality Control in cross-functional forums, ensuring alignment with organizational goals.
- Collaborate with teams across CMC Development, Manufacturing, Supply Chain, Regulatory, and Quality Assurance.
Compensation:
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.
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