Job Type : Contract 0-3 Month
Location/City : FL - Cocoa
Category : Quality
Region : Southeast
Id : 25440
Short Term Contract Assignment 45 Days
M-F 40 hours weekly, ASAP Start
Performs prescribed tests and inspections on raw materials, In-process, final product and stability. Ensure adherence to company and regulatory quality standards/specifications for a combination product (drug/device). The Quality Analyst will also conduct receiving inspection/test for components, raw materials, assemblies; conducts in-process inspections. It will also review and approve data and tests from other analysts or technicians and will be leading the overall training activities of new QC personnel. The analyst may also be involved in method validations and QC instrumentation qualifications.
I. Essential Functions and Responsibilities
Retrieves samples and performs prescribed analysis, including tests for critical characteristics.
Conducts other tests and investigations and also performs equipment calibrations and generates QC certificates
Cleans and maintains the lab equipment and physical lab space
Conducts in-process, stability and finish product release test
Provides support function for non-conforming product
Participates in the development and revision of procedures for inspection and test function
Generates periodic reports for the analysis of testing and inspection activities
Perform method and equipment validation or qualifications
Train other QC Lab personnel
I. Other Duties and Responsibilities
Maintain instruments and QC Labs facilities in order and as per required conditions and cleanliness standards
Calibrate more complex instruments or review/approve data from service suppliers for HPLC, FTIR, GCs, etc.
Know and follow all QC Lab safety rules and requirements
Design method validation protocols for review and approval
Participate on research testing QC testing and activities in support of Client products
I. Knowledge and Skills
Science degree or technical discipline. Advance studies a plus.
3+ years’ experience working in an analytical laboratory. Experience in GMP working environment a must.
Experience with analytical test equipment such as GC, HPLC, and FTIR or similar analytical equipment
QC Instrumentation calibration principles and concepts knowledge.
Two to Three years recent experience working in medical device/pharma manufacturing environment with a strong working knowledge of cGMPs (21 CFR 211 NS/OR 21 CFR 820/ ISO 13485
Must have strong organizational skills with attention to detail and accuracy
Must be able to work in a fast paced environment
Proficiency in the use of MS Word, Excel and Outlook. MS Access and other software a plus
Fluent in English, fluency in other languages a plus
QC Laboratory environment
|How to Apply:|
|Please send your resume in Word or PDF format to: firstname.lastname@example.org|
|Copy and Paste the following job title and code and place it in the subject line of your email so we can identify the job: Laboratory Analyst (#25440-MH1639)|