LL01-251118 Quality Control Scientist III

Job Description

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.