Bio-Rad's "Team 925 Awesome" documentation team is looking for new talent to join their multifunctional team to support the manufacturing activities of this large and reputable biotech company. In this role, you will be responsible for working with cross-functional teams to execute our long-term document management strategy.
- Files/Archives production and packaging quality batch records.
- Revise dispensing and packaging procedures.
- Collaborates with the Quality department to manage and track Change Requests.
- Revises manufacturing label content and templates.
- Executes core documents relating to chemicals, biological materials, and plastics.
- Reviews documents for the approved format, content accuracy, and compliance with existing procedures, providing feedback on the content as appropriate in collaboration with area experts.
- Creates and revises label specifications templates (LCRs) and processes manufacturing updates through DIR workflow.
- Maintains the Document Storage Area for all controlled documents.
- Assists with laboratory and general maintenance documents to support ISO13485 compliance requirements.
- BA/BS in Life Science (Candidates with masters' degrees in Life Science are highly preferred).
- 2-4 years experience in a documentation environment.
- Experience with chemical or biological techniques is preferred.
- Ability to work independently with minimal supervision after initial training on a process.
- Ability to multitask and manage time effectively to work in a fast-paced, dynamic environment.
- Able to be flexible and adaptable to unexpected changes in schedules and deadlines.
- Hands-on experience with SAP ERP systems and ISO13485 regulations is desirable.
- Proficient with Microsoft Word, Excel, and PowerPoint. Additional experience with statistics software.
- Strong verbal and written communication skills.
- Result-oriented with attention to detail preferred.