QA Raw Material Coordinator
Proclinical is currently recruiting for a QA Raw Material Coordinator with a global pharmaceutical company located in Philadelphia, PA. Successful candidate will coordinate and perform the responsibilities of the Quality Assurance Raw Materials Program (QAR) including receipt, storage, inspection, sampling, testing and disposition of materials.
- Assist in the preparation of Standard Operating Procedures (SOPs). Assists in the documentation of Non-conforming events (NCEs).
- Reviews laboratory test data and performs inspections in accordance with current Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), for nonclinical laboratory studies and Points to Consider (PTC) guidelines. NOTE: This is a 3rd shift position.
- Perform daily activities for QAR and maintains and continually aids in building QA Raw Material Systems.
- Perform physical inspection of raw material containers upon receipt to ensure the correct items ordered were delivered and were not damaged during shipping.
- Sample raw materials for release during testing, as necessary.
- Perform inspection and ensures proper testing of raw materials is performed in accordance with release procedures.
- Review inspection and testing data and directs disposition of materials after all release criteria have been evaluated.
- Prepare and distribute certificates of analysis/conformance as required. Participates directly in audits of assigned areas.
- Inspect in-house areas, discusses conditions/practices with appropriate personnel, documents and reports findings to Management and follows-up as needed.
- Conduct the reviews of raw data, batch records and test results, in accordance with cGMP, GLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner.
Skills and Requirements:
- High School diploma or equivalent required, Bachelors' degree in a Science related field preferred or equivalent experience.
- 3 -5 years of relevant experience or equivalent.
- Excellent oral and written communication skills.
- May be required to work overtime.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Dominic Santoro at (+1) 215-531-5280 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.
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