Associate II, Quality Control
Norwood, MA 02062 US
Target PR Range; 30-36/hr
*Depending on experience
Seeking an Associate II (Contractor) with cGMP quality control analytical testing experiences. The individual in this role will perform in process, release and stability testing in quality control Chemistry laboratory. Also, this individual may support special projects as assigned. This position will be the first shift from Monday to Friday.
Here’s What You’ll Do
Work on in-process, release and stability testing for raw materials, drug substance, intermediates, and drug products in accordance with cGMP, SOP, FDA, ICH and other regulatory requirements.
Routinely use analytical equipment including, but not limited to HPLC, UPLC, LC-MS, GC, UV plate reader, particulate matter, particle size analysis with Dynamic Light Scattering, KF, Osmolality, etc.
Follow current test methods and/or protocols to perform analytical testing
Document the testing procedure and results using Assay Performance Worksheets and/or LIMS as per GDP requirements and submit data packets for review
Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.
Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.
May assist with troubleshooting of assay methods and equipment.
Involve in lab event (LE), OOS, OOT, OOE and deviation investigations
May Implement CAPAs and perform effectiveness check.
Complete on job training activities
Involve in supply management to ensure there are sufficient reference standard, reagents, supplies prior to your testing
Review/write/revise SOPs, protocols and reports
Establish and maintain a safe laboratory working environment
Supports special projects as assigned
Additional duties as may be assigned from time to time
Here’s What You’ll Need (Minimum Qualifications)
BA/BS in Chemistry (preferred) or other relevant scientific discipline
Working experience: at least two years in quality control laboratory in a pharmaceutical company
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Solid experiences with general laboratory operations (Micropipette and analytical balance use, pH, reagent preparation, centrifuge, etc.)
Practical working knowledge of QC instrumentation and related software
Hands on experience with HPLC and UV instrumentation and chromatographic software
Strong technical writing ability
Proficiency with Microsoft Office Programs
Familiarity with electronic databases (e.g. LIMS, SAP, LMS, Veeva, Chromeleon, or equivalent software)
Strong written and oral communication skills as well as organizational skills
Demonstrated ability to work effectively under established guidelines and instructions
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.