Job description

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Job Description:

• Actively participates in the development, review and delivery of policies, procedures, practices, and training which support continual improvement of the site EH&S and Quality Management System (EH&SQMS)Assists with screening and communicating environmental regulatory requirements relating to the development and manufacture of APIs
• Serves as EH&S representative for key environmental programs, prepares meeting agendas, addresses technical concerns, and ensures preparation and distribution of meeting minutes
• Communicates cross-functionally: Routinely interfaces with R&D, materials management, and manufacturing personnel to identify regulatory requirements at early stage of process developmentMaintains records relating to environmental management system initiatives and projects, records of regulatory filings and correspondence
• Fields questions from consultants and laboratories relating to new substance registration programs. Monitors and measures performance in relation to contractual obligations and project deadlines
• Gathers data for the purposes of regulatory reporting and for monitoring, measuring, and communicating environmental performance; prepares report submissions
• Participates in internal management system and monthly regulatory compliance audits, prepares reports, monitors and tracks the status of compliance projects
• Develops and delivers training to departmental groups relating to management system conformance and regulatory compliance
• Utilizes established systems and practices to determine and develop approaches to routine problems of moderate complexity, based on analysis of situation or data.

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.

Job Types: Full-time, Contract

Pay: Up to $38.00 per hour

Application Question(s):

• Experience of screening and communicating environmental regulatory requirements relating to the development and manufacture of APIs?
• Experience of representing for key environmental programs, preparing meeting agendas, addressing technical concerns, and ensuring preparation and distribution of meeting minutes?
• Experience of generating data for the purposes of regulatory reporting and for monitoring, measuring, and communicating environmental performance; prepares report submissions?

Work Location: One location