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- Binghamton, NY
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Stability Lab Specialist - Quality Control
The Judge Group • Binghamton, NY
Posted 3 days ago
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Job Req # 562469
Pharmaceutical Company is looking for:
POSITION: Stability Lab Specialist – Quality Control
LOCATION: 40 miles outside or Binghamton New York Area
STATUS: No Visa Sponsorship
EXPERIENCE: 2+ Years Experience
RELOCATION: Assistance Available.
Pharmaceutical Manufacturing Company has an immediate opening for a Stability Lab Specialist with cGMP Manufacturing lab and Stability Studies experience. Company offers very good compensation and excellent benefits package and Company culture which is very pleasant and collaborative.
GENERAL RESPONSIBILITIES :
Reliabilty and Study Protocol Management
Create, review, and/or approve batch specific stability study protocols and summary report tables
Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols;
Calculate sample quantities required for testing by reviewing the applicable test methods, and calculate number of samples required per study based on pack types and storage conditions
Study Scheduling and Implementation
Maintain schedule of stability pulls, testing deadlines, and reporting deadlines
Dispose of samples when study is completed or discontinued
Participate in stability improvement projects
Ensure samples are labeled properly and distribute to appropriate stability chamber(s) for storage
Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications;
Material / Product Release
Approve, review and release raw material, in-process intermediates, product substances and drug products testing under current Good Manufacturing practices (c-GMP).
Review and approve all transfers from production and packaging to Quality Control to ensure successful implementation of new processes in production
Review, update and approve raw material, in-process and product specifications via the change control system.
BS in science plus pharmaceutical QC laboratory experience, or equivalent combination of education and experience
2+ years experience in a cGMP laboratory environment
Experience in GMP quality control and/or pharmaceutical manufacturing facility.
Excellent oral and written communication skills, strong organization, and interpersonal skills
Proficient in computer use (Word, Excel, PowerPoint, internet) with ability to learn new computer applications, requires intermediate to advanced Excel skills;