Document Control Specialist I

Rentschler Biopharma SE; Milford (MA); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Medical insurance

401K program

Job summary

Rentschler Biopharma SE in Milford, MA is seeking a Documentation Control Specialist to manage and verify records in our Quality group, ensuring compliance with regulatory requirements and cGMP standards.

You will issue, reconcile, and archive logbooks and batch records, support inspections and audits, and help maintain a robust electronic quality management system using MasterControl. Strong attention to detail and teamwork are essential.

Qualifications

• Experience in Document Control or Quality Assurance in a regulated biotech/pharma setting.
• Strong knowledge of FDA and cGMP requirements.
• Excellent attention to detail and organizational skills.

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 compliance

cGMP knowledge

MS Office

Tools

MasterControl

Job description

locationsMilford, MA, United Statestime typeVollzeitposted onVor 3 Tagen ausgeschriebenjob requisition idJR2846Advancing 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 ResponsibilitiesSupport 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 documentsSupport Regulatory Inspections and Customer AuditsSupport 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 requiredQualifications1+ 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 requirementsExperience with electronic quality management systems such as MasterControlStrong attention to detail and great organizational skillsMust be a strong team player with good problem solvingExcellent verbal and written communication skills and proficiency in Microsoft software applicationsPhysical RequirementsAbility to lift 5 to 10 lb boxes of documentation when performing archiving duties____________________________________________________________________________ Base Pay Range$70,000 - $80,000Disclosure StatementRentschler 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.Brauchen Sie Hilfe?Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team: [e-mail]