Pharmaceutical QA / Regulatory Affairs CMC Documentation Specialist
Quick Apply Full-time 4 hours ago Full Job Description American Injectables is a privately held Florida based domestic manufacturer of injectable drug products for the US Hospital markets, leading the push for vertically integrated US injectable manufacturing.
We offer competitive wages and provide a comprehensive benefit program which includes Medical, Dental, Vision and 401K, amongst other benefits.
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.
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, especially 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.
Qualifications:
Required Skills/Abilities:
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.
Education/
Experience:
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 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.
Training:
Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
Must successfully complete all material handling training/verification as part of ongoing training.
Job Type:
Full-time
Benefits:
401(k) Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Schedule:
Monday to Friday Ability to commute/relocate:
Brooksville, FL 34604:
Reliably commute or planning to relocate before starting work (Preferred) Education:
Bachelor's (Preferred)
Experience:
CMC filing documentation development/review:
3 years (Preferred) Work Location:
One location Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
We offer competitive wages and provide a comprehensive benefit program which includes Medical, Dental, Vision and 401K, amongst other benefits.
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.
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, especially 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.
Qualifications:
Required Skills/Abilities:
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.
Education/
Experience:
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 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.
Training:
Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
Must successfully complete all material handling training/verification as part of ongoing training.
Job Type:
Full-time
Benefits:
401(k) Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Schedule:
Monday to Friday Ability to commute/relocate:
Brooksville, FL 34604:
Reliably commute or planning to relocate before starting work (Preferred) Education:
Bachelor's (Preferred)
Experience:
CMC filing documentation development/review:
3 years (Preferred) Work Location:
One location Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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