Document Control Specialist I

Rentschler Biopharma Inc.; Milford (CT); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Discretionary bonus

Medical insurance

401K program

Job summary

Rentschler Biopharma Inc. in Milford, MA seeks a Documentation Control Specialist to manage and verify document records in our Quality group, ensuring regulatory compliance and cGMP standards.

You will issue logbooks, reconcile batch records, support audits and inspections, and maintain electronic QA records using MasterControl and Microsoft Office.

Qualifications

• 1+ year experience in Document Control or QA in a cGMP biotech/pharmaceutical company or other similarly regulated industry.
• Experience with document indexing.
• Strong knowledge of FDA and cGMP requirements.
• Experience with electronic quality management systems such as MasterControl.

Responsibilities

• Support and manage documents and records in the electronic Quality Management System in compliance with regulatory requirements.
• Issue and reconcile logbooks, batch records and controlled forms.
• Maintain a record of inventory, storage, and transfer to offsite archive.
• Scan original records and ensure they are a true copy of the original documents.
• Support retrieval of records for audits, inspections, and related activity as needed.
• Format clear, detailed, and well-designed documents.
• Support Regulatory Inspections and Customer Audits.
• Support QA Document Control projects and initiatives as required.

Skills

Document control

Quality Assurance

FDA & cGMP knowledge

Attention to detail

Tools

MasterControl

Microsoft Office

Job description

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

Our Documentation Control Specialist within our Quality groups reviews as well as verifies document records to ensure the documentation complies with regulations and internal quality assurance practices. The Document Control Specialist will manage the document and record life cycle to ensure compliance with regulatory requirements and company procedures.

Duties and Responsibilities

• Support and manage documents and records in the electronic Quality Management System in compliance with regulatory requirements.
• Issue and reconcile logbooks, batch records and controlled forms.
• Maintain a record of inventory, storage, and transfer to offsite archive.
• Scan original records and ensure they are a true copy of the original documents.
• Support retrieval of records for audits, inspections, and related activity as needed.
• Format clear, detailed, and well-designed documents.
• Support Regulatory Inspections and Customer Audits.
• Support QA Document Control projects and initiatives as required.
• Ensure compliance with all regulatory standards, systems, procedures, and practices, including cGMPs and other regulatory requirements.
• Other duties as required.

Qualifications

• 1+ year(s) experience in Document Control or Quality Assurance with a cGMP biotech/pharmaceutical company or other similarly regulated industry.
• Experience with document and record indexing.
• Strong demonstrated knowledge of FDA and cGMP requirements.
• Experience with electronic quality management systems such as MasterControl.
• Strong attention to detail and great organizational skills.
• Must be a strong team player with good problem solving.
• Excellent verbal and written communication skills and proficiency in Microsoft software applications.
• Physical Requirements Ability to lift 5 to 10 lb boxes of documentation when performing archiving duties.

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Base Pay Range $70,000 - $80,000

Disclosure Statement Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.

Rentschler Biopharma is a contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. We live by the motto: Many hands, many minds - one team! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents, we pursue one vision together: advancing medicine to save lives.