Job Title: Quality Control Analyst II
Summary:
Are you someone who is interested in joining an innovative, niche and talented Biopharmaceutical company? My client is paving the way with a Nobel-prize winning technology to target four different therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases and CNS/ocular diseases. Another unique component of my client is the company culture - named one of the Top Places to Work in Boston six years in a row. If you are someone with excellent communication, organizational and interpersonal skills, this may be the opportunity for you!
The Quality Control Analyst II will be responsible for:
- Perform methods transfer and qualification for reference material program.
- Contribute to Deviations, Out of Trend (OOT) or Out of Specification (OOS) investigations.
- Have complete oversight of reference materials inventory management and shipping activities and act as a single point of contact for reference materials.
- Will support the coordination with Quality and Program Managers to provide project updates, workflows and timelines.
- Maintain and develop reference materials metrics for the Quality Management Review.
- Review and author technical documentation such at SOPs, protocols, etc.
The Quality Control Analyst II should have the following qualifications:
- Bachelor's Degree in Chemistry, Biochemistry, Pharmacology or related field.
- At least 2 years of related work experience (or equivalent combination of education experience).
- Must have hands-on experience with HPLC methods and Empower software.
- Must have excellent communication skills, be a team player, and ability to make presentations on relevant subject matter to upper management.
- Experience with LIMS (Laboratory Information Management System) is a plus.
- Strong experience with investigations, deviations and formal root cause analysis is preferred.
If this sounds like something that you would be interested, do not hesitate to apply!
