QC Analyst II
QC Analyst II
This growing biopharmaceutical company is looking for a QC Analyst II to be part of the team. Our ideal candidate will be responsible for reviewing data and providing justification documents for regulatory submissions, manage the life cycle for new and existing specifications, develop and maintain QC policies, SOPs, specifications, and specification justification reports.
- Devise, revise, and establish the life cycle management SOPs for specifications
- Responsible for reviewing data and providing justification documents for regulatory submissions, IMPD/IND/NDA
- Manage the life cycle for new and existing specifications.
- Develop and maintain QC policies, SOPs, specifications, and specification justification reports.
- Perform data analysis per release and stability data at contract labs and CMOs.
- Provide QC project management of timelines for cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.) to support IMPD/IND/NDA filings.
- Support Quality Control during GxP audits/inspections (internal and external) to assure adherence to company SOPs, and any applicable regulatory requirements.
- Serve as an SME for Quality Control specifications and stability during regulatory inspections.
- Support and develop risk assessments to determine level of compliance risk. Led the implementation of appropriate mitigation strategies.
- Direct operations including review of data, authorship of technical documentation, and inspection readiness. Provide QC technical support as needed.
- Understand the importance and priority of EHS and takes personal responsibility for their own safety; looks out for the safety of colleagues and avoidance of all incidents; willingly engages in and embraces activities to improve EHS performance in the working environment.
- Review analytical data for compliance with specifications and cGMP guidelines
- Preferably a Bachelors or Masters degree in Chemistry, Biochemistry, or science related
- At least 2 years' experience in a cGMP environment
If you or someone you know in your network is interested in this position, then please send an updated resume to the attention of N.Silvera (AT SIGN) realstaffing.com and her team at Real Staffing Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.