Job description

Title: QC Associate II, Stability
Location: Norwood MA
Duration: 6m+
Schedule: 1st shift Wed-Sat

Job duties:

• 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

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

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.

Regards,

Vivek Kumar

IDC Technologies.

Job Types: Part-time, Contract, Temporary

Salary: $25.00 - $32.00 per hour

Benefits:

• Health insurance
• Life insurance
• Paid time off

Experience level:

• 1 year

Schedule:

• Day shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing (Preferred)

Shift availability:

• Day Shift (Preferred)
• Night Shift (Preferred)

Work Location: One location

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