QC Analyst (12 Hour days) Job in Bethlehem 18017, Pennsylvania US
QUALITY CONTROL ANALYST
12 hour DAYS 7am to 7pm. 4-6 months with potential for direct hire but NO guarantee.
- Perform routine sample preparation and analysis with experience in at least 1 of the following instrumentation: (AA, GC, UN-VIS, FTIR), for in-process, finished, stability, raw materials and various biological samples created during RD and process development activities.
- Sampling, inspection and testing of raw materials upon receipt
- Sampling, inspection and testing of packaging components upon receipt
- Testing in-process material as directed in the applicable in-process specifications
- Testing bulk drug substance as directed in the applicable in-process specifications
- Testing finished drug product as directed in the applicable specifications
- Performing quality laboratory investigations response to out of specification, apparent failure or questionable results
- Proper documentations of all applicable activity
- Calibration of instrument when necessary
- Solution and calibration standards preparation
- Maintain lab notebooks
- Gas cylinder change-outs
- Packaging area inspections
- Maintaining the stability program, including sample acquisition, storage, testing examination and record keeping.
- Review production in-process records
- Follow SOP’s and maintain good documentation during work: data management and maintenance to ensure compliance for audit preparation.
- Write analysis reports and data QC for review
- Design and execute lab experiments with input from chemist and quality control manager
- Experimentally maintain and improve analytical methods, including: in-process sample and drug product release
- Keeps supplies ready by inventorying stock; placing orders; verifying receipt.
Requirements:
- BS in Chemistry mandatory
- 3-5 years experience in a cGMP Laboratory setting
- Familiar with GMP/GLP and FDA requirements and possess good documentation skills
- Person needs to be highly motivated and flexible, with excellent problem solving and interpersonal skills. The ability to work as part of a small team with other scientists and analysts are essential
- Strong oral and written communication skills with experience in writing SOPs and technical reports, including domestic and overseas regulatory filings
PLEASE EMAIL RESUME IN MS WORD DOCUMENT
August 16, 2007
• Tags: Pennsylvania Us, QC Analyst (12 Hour days) Job in Bethlehem 18017 • Posted in: General