RFD_Pharmaceutical Scientist 2

at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States

Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Pharmaceutical Chemist II position is an integral member of the Quality Control Analytical team supporting Stability and Release testing for the Laboratory. This colleague will support GMP analytical testing activities. The primary function of this position is to perform elementary and intermediate analytical and physical testing of pharmaceutical starting materials, components and finished products to client supplied and Pharmacopoeial methodology in accordance with regulatory standards with a high level of accuracy and minimal personal error. The Pharmaceutical Chemist II will have the ability to independently perform testing and analyze data. Analytical testing is performed using equipment such as FTIR, Karl Fischer, UV-VIS, HPLC, Dissolution and GC with calibration, maintenance and troubleshooting of this equipment. This position will require training of analysts in techniques for which competency has been demonstrated. In addition, the Pharmaceutical Chemist II will participate in OOS investigations and assist in the determination of root cause. There are no supervisory responsibilities.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
GENERAL RESPONSIBILITIES

Receipt and logging of samples into LIMS including setting up new product/test and specifications Works in an efficient manner to a high level of accuracy with minimal personal error Generation and documentation of raw data in accordance with cGMP and ALCOA principles Collect, process and analyze data Knowledge of USP/EP general chapters and ICH Guidelines which pertain to job function Training of other analysts in techniques for which expertise has been demonstrated On time completion of assigned training in ComplianceWire Participate in internal Health and Safety audits including developing actions and follow up Retains product upon completion of testing and retaining of raw data upon issuance of analytical report/CoA Maintains a high level of good housekeeping including ensuring that all glassware is disposed of and cleaned in a timely manner once analysis is complete and checked for compliance to specification Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence Ensure that all waste materials/solvents are disposed of in a safe and timely manner Leads/participates in implementation and execution of continuous improvement activities Plays a key role in creating and maintaining an atmosphere of teamwork throughout the laboratory This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Performs other duties as assigned by Laboratory Management

SPECIFIC RESPONSIBILITIES

Performs elementary chemical and physical testing as needed: Wet Chemistry (pH and Conductivity Testing), United States Pharmacoepia (USP)/European Pharmacoepia (EP) Monograph ID Testing, Loss on Drying Testing, Water Activity Testing, Disintegration Testing, Friability Testing, Weight Verification Testing, Identification Testing of products by HPLC, FTIR and UV-VIS spectrophotometer, and Physical Testing (Appearance, Flavor, Odor, Basis Weight and Overflow Capacity) for solid dosage and liquid dosage finished product release and raw materials testing. Performs intermediate chemistry and physical testing to support the commercial and clinical stability and release testing of raw materials and drug products using the following techniques in accordance with GMP, GLP and company testing methods:
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-Light Transmission by UV-VIS Spectrophotometer
-HPLC Testing (Assay and Content Uniformity Methods)
-Dissolution Testing (with end by UV-VIS or HPLC)
-Gas Chromatograph Testing (GC)
Plans and organizes work with periodic supervision and communicates testing results to Laboratory Management as needed Ability to interpret different customer method requirements with minimal supervision... For full info follow application link.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.