Associate II, Quality Control (1st shift Sun-Wed)
Norwood, MA 02062 US
Job Description The Role
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 third shift (10 pm - 8 am) from Sunday to Wednesday.
Heres What Youll 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
Heres What Youll 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
Heres What Youll 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.
Salary will be commensurate with experience
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