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  • Binghamton, NY

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Stability Lab Specialist - Quality Control

The Judge Group • Binghamton, NY

Posted 3 days ago

Job Snapshot

Degree - 4 Year Degree
Other Great Industries
QA - Quality Control


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Job Description

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

SALARY:  $60-65K

DEGREE:   Preferred

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.


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.

Qualifications :

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;

Job ID: 562469
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