QC Methods Development Scientist (cGMP - Pharmaceutical) JD818692
Boston, MA area
DPS Engineering is looking for a capable QC Methods Validation professional to support a Biopharma client in the Boston, MA area. This individual will be responsible for the development of new equipment, methodologies, concepts, techniques, and standards for Quality Control.
- Contributes to the development of new concepts, techniques, and standards. Considered a consultant (expert) within the group. Has complete understanding and application of principles, concepts, practices, and standards.
- Responsible for conducting analyses of raw materials, manufacturing samples, in-process and finished products and formulations according to SOPs.
- Compiles data for documentation of test procedures and prepares reports.
- Review IQ/OQ/PQ protocols and final reports for instrument system upgrades. Generates PQ protocols.
- Bachelor's Degree in Life Sciences.
- At least 5+ years of related experience or equivalent combination of education and experience.
- Extensive knowledge of QC testing principles and procedures.
- Extensive exposure to cGMP environment.
- Knowledge of testing and associated equipment protocols and requirements and applicable instrumentation and procedures.
- Strong interpersonal and communications skills; written and oral.
- Solid understanding of applicable regulatory requirements.
- Significant laboratory documentation review and revision experience.
- Ability to function well in a fast-paced environment.