QC Scientist II, Analytical Chemistry (3rd shift)

Pharmaron•Coventry, RI

17h•Onsite

About The Position

This position will support manufacturing and process chemistry activities through analytical method validation, transfer, sample testing and ensuring QC lab in compliance with all applicable guidelines. 3rd shift, working hours: 11:00 pm- 7:30 am. Must be open to working 2nd shift (3pm -11:30am) as business requires.

Requirements

BS or MS degree in chemistry or related field
2+ Years of pharmaceutical industry experience
Ability to perform routine QC work independently with minimal guidance
Proven skills in analytical method verification and validation of small molecules
Effective in managing multiple competing activities and delivering to timelines
Ability to work in a cross-function environment
Experience in HPLC, GC, FTIR, UV and wet chemistry
Working knowledge of cGMP and applicable FDA, EMA and ICH guidance
Excellent communication skills, both verbal and written

Responsibilities

Sample raw materials and conduct QC testing of raw materials, intermediates, API, IPC and cleaning verification samples following established procedures.
Document and report results of all experiments in a timely-manner consistent with department practices and governing procedures, as applicable.
Participate in method transfer or validation activities, including executing the protocols and preparing the reports.
Review experimental data, notebooks, and instrument qualification protocols / reports.
Write, revise, develop, and evaluate SOPs.
Maintain good laboratory practices and GMP in compliance with safety and environmental requirements.
Ability to work successfully in both a team/matrix environment as well as independently.
Report lab event or deviation and participate in the investigation.
Ensure high quality in QC and analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
Provide training to other team members on instrument and testing method.
Participate, support and facilitate site audits as directed and required.
Perform other related assignments and duties as required and assigned.