Similar posts
QC Analyst
- Permanent
- Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
- United States
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a QC Analyst with a leading biopharmaceutical company located in Boston, MA. As the QC Analyst, you will plan and support execution of internal as well as outsourced analytical testing, analytical qualifications, and stability studies of exosomes, biological molecules, oligonucleotides, small molecules, and drug products.
Job Responsibilities:
- Drafting stability protocols, trending/reviewing stability data, writing stability reports
- Performs routine and stability testing in the laboratory.
- Review of release, stability, and characterization data, including technical review of change control documentation and reports, deviations, and OOS.
- Assist in outsourcing of release and stability test methods, including test method transfer, assay qualification and troubleshooting.
- Collaborate with Analytical Development on identifying, developing, and qualifying test methods to support phase-appropriate product release and stability testing.
- Work collaboratively with Upstream PD, Downstream PD, Analytics, and Research groups to develop an increased depth of knowledge of processes and identify improvement opportunities.
- Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
- Generate complete, accurate, and concise laboratory documentation.
- At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.
Skills and Requirements:
- BS and/or MS degree in biochemistry, cell biology and/or molecular biology discipline.
- At least 3 years work experience in a GMP environment.
- Background in QC Stability Studies.
- Background in methodologies supporting both biologics and small molecules.
- Direct experience in authoring and review of SOPs, assay qualification protocols and reports.
- Strong knowledge of cGMP/ICH/FDA/EU regulations.
- Work with minimal supervision, demonstrated ability to troubleshoot, quickly design and execute thoughtful experiments leading to innovative solutions.
- Strong work ethic and strives to learn new things, and capable of working independently and in a collaborative environment.
- Excellent communication, project management, and presentation skills (oral and written);
- Proven track record of being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator.
If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-SA1
Related jobs
US$25 - US$30 per hour
Norton, USA
Proclinical is on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.
Highly Competitive
Visp, Schweiz
Proclinical is seeking a QC Analyst to join our client's team in Switzerland.
Highly Competitive
Solothurn, Switzerland
Proclinical is seeking an Associate Quality Control professional to join our client's team in Switzerland.
Highly Competitive
Basel-Stadt, Schweiz
Are you passionate about quality and precision? Join our client as a dedicated Quality Manager and help ensure top-tier standards every day.
Highly Competitive
Visp, Switzerland
Proclinical is seeking a QC Associate to join the Bioanalytics Microbial Team at our client's facility.
US$0.00 - US$25 per hour + Highly Competitive Salary
Fremont, USA
Proclinical is seeking a Maintenance Technician to ensure the smooth operation of facility systems and equipment.