Position Summary

The Quality Assurance Regulatory Specialist is a quality focused individual who ensures documentation and record keeping processes conform to cGMP and regulatory requirements as well as Bell Int. Labs approved procedures and output documents are accurate. The individual will assist in the day to day record management activities within Bell Labs complying with company and regulatory requirements.

Job Type
Full Time
Benefits
401K, Vision, Dental, PTO
Responsibilities

• Support our customers through provision of requested regulatory documentation.

• Coordinate and prepare routine submissions for FDA and other regulatory bodies

• Monitor applicable regulatory requirements to assure compliance with domestic and foreign regulatory standards.

• Maintain regulatory approvals and associated files. Build and maintain “regulatory library”.

• Provide regulatory feedback to R&D regarding proposed product ingredient lists.

• Review customer artwork for regulatory compliance.

• Support R&D during development process to ensure formulas are compliant in the applicable regulated countries.

• Identify and create efficiencies in the facilitation of regulatory process.

• Assist the Document Control Specialist: Performs QA document control functions, including document login, tracking, processing, review, distribution, release and archiving of documents as needed.

• Assist Document Control Specialist in maintaining change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols, reports, and other GMP documents.

• Actively participates in internal audits, customer audits and other activities as assigned by manager.

Requirements

• BS/BA in science, engineering, quality/regulatory degree or equivalent industry experience in pharmaceutical regulatory affairs.

• Quality professional with 2-5 years of hands on experience with regulatory management in a regulated pharmaceutical industry with direct regulatory experience.

• Must be well-organized and proficient at reviewing and editing documentation.

• Can maintain attention to detail while executing multiple tasks.

• Must be skilled in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat.

• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.

• Ability to effectively build and maintain relationships, communicating and interacting in a matrix environment

Additional Information

Preferred Requirements:

• Exhibit a quality mindset and a willingness to develop yourself and others.

• Demonstrated knowledge of GMPs, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.

• Audit or inspection experience preferred.

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