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Sr. QC Associate, Analytical
2 months ago
- Lead project groups to complete objectives in a timely manner. Manage project related schedules. Collaborates with Operations, Process Development, and external clients. Presents project progress and scientific updates to internal and external parties.
- Develop, qualify, and validate complex analytical test methods following international guidance’s, and client requirements.
- Mentors quality control associates. Ensures personnel understand various analytical assays and standard operation procedures as well as conform to any departmental procedures.
- Develop and revise SOPs under data integrity guidelines as well as perform periodic revisions to ensure the procedures are up to date to current standards.
- Assist Quality Assurance in ensuring compliance with applicable quality standards and regulatory requirements.
- Lead QC initiatives. Develop and implement improvement projects seeking in-put from affected departments / parties as needed.
- Bachelor, Masters, or PhD of Science Degree in the Biological Sciences, Bioengineering or Chemistry with a combination of education and experience performing biochemistry, molecular biology, microbiology, and chemistry.
- 8+ years relevant experience with BS, 6+ years relevant experience with MS, or 0+ years relevant experience with PhD required
- Up to 5% travel
- The QC Associate Senior must be accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
- The QC Associate Senior must be capable of being highly independent, and able to accomplish tasks with minimal input.
- The QC Associate Senior must be capable of mentoring other quality professionals and working closely with other departments.
- The position is responsible for performing and demonstrating the highest form of quality in the pharmaceutical industry, understanding the cGMP regulations, and implementing these practices on the work being performed.
- Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
- Highly organized, detail oriented, with excellent record keeping skills.
- Sound scientific judgement with good communication skills and the ability to work effectively with others.
- Experience working in a GMP facility is highly desirable.
- Experience analyzing plasmid DNA is highly desirable.