Title: QC Associate II, Stability

Location: Norwood, MA

Job Type: Contract

Schedule: M-F 8-4pm

Job Duties:

Work on in-process, release, and stability testing for raw materials, drug substances, 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 with data integrity and cGMP in the QC lab in line with 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 the troubleshooting of assay methods and equipment.

Involve in lab event (LE), OOS, OOT, OOE and deviation investigations

May implement CAPAs and perform an 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

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

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.

Job Types: Full-time, Contract

Salary: $25.00 - $35.00 per hour

Experience level:

• 2 years
• 3 years

Schedule:

• Day shift

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

Speak with the employer
+91 8400858336

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