Document Control Specialist I
Rentschler Biopharma
Summary
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.
Job description
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
Requirements
- 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
Benefits
- Annual discretionary bonus program
- Medical insurance
- 401(k) program
Company overview
Rentschler Biopharma is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical services. Founded in 1872 and now in its fifth generation as a family-owned company, Rentschler Biopharma has over 50 years of experience in biopharmaceutical manufacturing. The company operates from two main sites: its headquarters in Laupheim, Germany, and a facility in Milford, Massachusetts, USA. With approximately 1,400 employees, Rentschler Biopharma offers comprehensive full-service solutions for bioprocess development and manufacturing of complex biopharmaceuticals, including analytical development, process development, formulation development, cGMP manufacturing, and regulatory affairs consulting. The company has an impressive track record, having contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023 and serving over 180 clients worldwide since 1997. Rentschler Biopharma specializes in complex molecules, with more than 50% of their modalities being complex proteins including advanced antibody formats and recombinant enzymes. The company is known for its reliability, quality management systems, and operational excellence philosophy that ensures product quality and productivity at every development and manufacturing stage.