Overview

The CMC Document Specialist is responsible for developing, reviewing, and managing technical documentation related to chemistry, manufacturing, and control (CMC) activities within the pharmaceutical industry. This includes preparation and submission of regulatory documents, development of quality systems, and management of documentation related to process development, manufacturing, analytical testing, and quality control.

Responsibilities

Develop and maintain CMC documentation for pharmaceutical products in accordance with applicable regulatory requirements and guidelines, including IND, NDA, and ANDA submissions.
Manage document preparation, specially technical writing, editing, formatting, indexing, to enable consistency in document writing and sharing of documents with regulatory affairs as well as external parties, including partners.
Work closely with cross-functional teams, including process development, manufacturing, analytical development, and quality control, to ensure that all CMC documentation is accurate, complete, and timely.
Maintain knowledge of current regulatory requirements and industry trends related to CMC documentation, and provide guidance and recommendations to internal stakeholders on regulatory compliance and best practices.
Review documents for completion and accuracy, maintain a Master Documentation list, and provide notification that documents are revised, effective or obsolete.

Requirements

Qualifications

Direct experience authoring and reviewing technical documents to support drug product filings.
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines and ensuring the most efficient regulatory process.

Job Description

Bachelor s degree in a scientific or technical field, such as chemistry, biochemistry, or pharmaceutical sciences.
Minimum of 3 years direct related experience supporting CMC filing documentation development and review for ANDAs.
Experience in a cGMP regulated pharmaceutical sterile manufacturing environment (Preferred)
Experience with cGMP Documentation e-Systems
Good verbal and written communication skills
Experience with Microsoft applications

Physical Requirements:

Employee may be required to lift or handle objects not more than 25 lbs to perform certain duties essential to the job function.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.

The QA/RA CMC Documentation Specialist plays a critical role in ensuring compliance with regulatory requirements and internal quality standards, and is an essential member of the cross-functional team responsible for developing and manufacturing pharmaceutical products. If you have a passion for documentation and a strong understanding of regulatory requirements in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.

Education and Experience Bachelor s degree in Chemistry, Biochemistry. Minimum of 5 years experience in an Analytical QC role supporting a sterile pharmaceutical manufacturing operation. Minimum of 2 years supervision Knowledge of current USP standards Knowledge of microbiological and analytical laboratory techniques Knowledge of sterile technique Experience with microbiological and analytical instrumentation Knowledge of FDA/USP guidelines Excellent verbal and written communication skills Analytical reasoning, root cause analysis and problem solving Technical writing: write, read, understand, and interpret technical writing and instructions MS Office skills; particularly Word and Excel Math and calculation skills Multitask and coordinate with operations and quality assurance simultaneously Work with a wide range of people to solve problems and resolve issues Work in a fast-paced environment Ability to maintain flexible task schedule and workflow Highly detail oriented with good record keeping skills Excellent people skills, with experience collaborating in a multi-disciplinary, diverse, and dynamic team

Electrical facilities engineer