Quality Control Scientist III

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Quality Control Scientist III

Qualifications:

Bachelor's Degree in Science.

Minimum of 8 years of experience in direct pharmaceutical quality control areas and regulatory operations.

Must be fully bilingual (English / Spanish) with excellent oral skills.

Must be proficient using MS Windows and Microsoft Office applications.

Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.

Strong knowledge (according to related area).

Technical Writing skills and investigations processes.

Available to work extended hours, possibility of weekends and holidays.

Responsibilities:

Evaluate compendial changes from the different pharmacopeias.

Generate trend reports of investigations based on the company’s procedures.

Evaluate global documents against site-specific procedures and update the site procedure accordingly.

Draft technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports, based on corporate policies, SOPs, compendial guidelines, ICH, DEA, and FDA regulatory guidance.

Generate required change requests for analytical documents and route documents for review and approval.

Conduct laboratory event/out-of-specification/out-of-trend investigations and close them on time.

Full-time