Manufacturing Document Clerk
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Job Location:
Allendale County, SC - USA
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions MTG has the knowledge and experience to ensure compliance with pharmaceutical biotechnology and medical device safety and efficacy guidelines. With offices in Caguas PR Boston MA & San Francisco CA we serve life sciences clients in six global markets: United States Puerto Rico Dominican Republic Mexico Germany Canada and South America.
Position Overview
We are seeking an experienced Document Clerk to support our pharmaceutical and biotechnology clients by managing organizing and maintaining critical documentation in compliance with FDA cGMP and ISO standards. This role ensures accuracy accessibility and regulatory compliance of all records contributing to efficient quality and operational processes across projects.
Key Responsibilities
- Partner with Quality Assurance and Regulatory Affairs teams to manage controlled documents.
- Maintain electronic and physical document control systems ensuring proper versioning access and security.
- Receive log and organize all incoming and outgoing documentation related to production quality and regulatory processes.
- Prepare review and distribute controlled documents including SOPs batch records validation protocols and regulatory submissions.
- Support audits and inspections by providing accurate and timely retrieval of documentation.
- Track document revisions approvals and expiration dates to ensure records remain current.
- Coordinate with cross-functional teams to facilitate timely submission review and approval of documents.
- Generate reports and metrics to support management oversight and quality monitoring.
- Ensure strict compliance with company policies cGMP FDA and ISO requirements.
Qualifications & Requirements
- Associates degree or higher in Life Sciences Business Administration or a related field.
- 25 years of experience in document control or clerical support in a regulated pharmaceutical or biotech environment.
- Knowledge of cGMP FDA and ISO documentation standards.
- Proficiency with electronic Document Management Systems (eDMS) and Microsoft Office Suite.
- Strong organizational skills with exceptional attention to detail.
- Excellent communication teamwork and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced regulated environment.
Preferred Qualifications
- Experience with eDMS systems such as Veeva Vault or MasterControl.
- Exposure to regulatory submissions validation documentation or quality audits.
- Knowledge of pharmaceutical manufacturing processes and lifecycle documentation.
- Demonstrated ability to maintain confidentiality and handle sensitive information.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza color religión sexo orientación sexual identidad de género información genética origen nacional estado de veterano protegido estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by law.
Required Experience:
Junior IC
Key Skills
About Company
Maintain compliant, reliable operations in life science and highly regulated industries with multidisciplinary services from a minority-owned partner, Mentor.
