Job Description :
Job Title: Scientist - Senior
Job Location: Lexington, MA
Client: Pharmaceutical
Duration: 7+ Months (possibility of extension)
Description
Lead or support the execution, and data analysis of assay validation, method transfer(co-qualification) studies in the QC laboratories. Support completion of all protocols and validations in a timely and appropriate manner.
Contribute to the evaluation of new methodologies and transfers to determine business need and applicability to the area. Perform evaluations/testing as related to improvements or project. Provide recommendations for or implement instrumentation upgrades or improvements to drive optimal performance.
Author or support the writing of technical memos, reports, protocols, studies and other appropriate documentation to support laboratory validations, investigations and/or objectives.
Frequent use and general knowledge of industry practices, techniques, and standards. Provide technical support to the QC Laboratories.
Support global standards/strategies in continuous improvements.
Comply with control of lab documentation. Review data with application of good documentation practices. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations.
Assure compliance with company procedures, quality and regulatory requirements, and regulatory guidance documents including QSR, cGMP, USP, CFR, and compendia literature. Support and implement laboratory systems and/or guidelines to meet compliance requirements.
Support regulatory and non-regulatory audits (e.g. Internal Quality Assessment, Corporate, FDA, etc
Support regulatory submissions /change control requests in a timely manner when required.
Proactively an actively contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
Support technical presentations and/or training to QC Laboratories (including management) as needed.
Ensure personal training requirements are met and training records are current.
Stay current in the technical and compliance field regarding lab instruments and methods.
Perform Disposal of Hazardous Waste as required.