Gmp Data Reviewer Jobs in Kansas (NOW HIRING)

Company Description
Job Description
Position Details:Job Title: Analytical Chemist I
Duration: 12 months contract, extendable up to 18 months
Location: Mcpherson, KS
Note:
Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
You may participate in the company group medical insurance plan which includes dental and vision.
Job Description:
The R&D Pharm Sci. team member will be involved in multiple, on-going projects. Activities include performing analysis in a GXP environment and may include material qualification (excipients or active pharmaceutical ingredients), release testing, and analysis required to support manufacturing functions (engineering, exhibit batches, etc), as well as on-going stability studies. The individual should have good communication and organizational skills and be able to coordinate work with cross-functional team members, peers, and external CROs (Contract Research Organization).
Position Responsibilities
Perform testing using analytical equipment (i.e. UPLC, HPLC, GC, Karl Fischer, pH, UV-Vis, IR, microscopy, optical rotation) as well as using traditional wet chemistry methods (i.e. titration, TLC, sulfated ash, etc.)
Enter experimental information into hard-bound and electronic lab notebooks (i.e. Biovia eLN) and process analytical data accordingly (i.e. Empower 3, Excel, etc).
Perform additional data entry, processing, and review within LIMS system (i.e. Thermo LIMS).
Coordinate with team members to ensure seamless analytical coverage during manufacturing campaigns and on-going stability studies. Also support new project activities, as needed.
Perform analytical method feasibility, development and validation, as necessary.
Coordinate with team members to verify each other's data by reviewing eLN and LIMS entries in a timely manner.
Take personal responsibility to meet analytical testing and data verification deadlines, as well as safety and training requirements.
Author protocols, reports, or other technical documents, and presents project data to group, as needed.
Organizational Relationships
Primary interaction will be with Pharmaceutical McPherson PEH PharmSci R&D group. Will also work with other product development groups including GTS and Pharmaceutical Center One.
Pharmaceutical McPherson Chemistry Quality group.
Pharmaceutical McPherson Manufacturing.
Possible interaction with CROs
Education And Experience
Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
BS and 3-7 years experience in a regulated industry (i.e. food, pharmaceutical, biotech, petroleum, etc).
MS and 2-5 years experience in regulated industry
PhD and 1-5 experience in regulated industry
Technical Skills Requirements
Indicate the technical skills required and/or preferred, as applicable.
Hands-on experience with complex analytical equipment including IR, UV-Vis, imaging systems, chromatography systems (UPLC, HPLC, GC) and chromatography methods (RP, IC, SEC, etc).
Experience using simple analytical tools including KF titration, microscope, polarimeter, pH, analytical balances, density meter, osmometer, and etc. is required.
Experience with simple and/or complex analytical method verification, development, transfer, or validation strongly preferred.
Experience working in a regulated (i.e. FDA, TTB, etc) or GMP environment is strongly preferred.
Understanding of various scientific software or software used in pharmaceutical or production environment (i.e. eLN, LIMS, Empower 3, Trackwise, MiniTab, Fusion, etc) would be preferred.
Strong analytical reasoning skills.
Excellent written and verbal communication skills.
Physical Position Requirements
Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc. Please include any hazardous materials or non-standard working environment the contractor will have exposure to which may require additional medical testing and/or apparatus fitting for OSHA compliance.
May work with hazardous chemicals including acids, bases, oxidizing agents, carcinogens, mutagens, teratogens, etc.
Additional medical testing will be required.
PPE training, solvent respirator and powder respirator training and fitting will be required.
Occasional weekend and evening work is required.
May sit or stand at bench for extended periods.
Qualifications
Additional Information
Anuj Mehta
732-947-3452