Reporting to the Manager, Quality Assurance, we are looking for a Documentation Specialist who has experience creating and reviewing quality system documentation, organizing and managing archival records. The preferred candidate will have demonstrated attention to detail, experience in collecting, organizing and storing controlled documents. The Senior Documentation Specialist role is available to qualified candidates.
The Document Specialist is responsible for managing documents and records in paper and electronic format to ensure a constant state of compliance with GMP requirements and internal procedures. The Document Specialist will assist and support all Quality staff in organizing, storing and archiving all paper and electronic documentation. The role will be responsible for indexing and organizing paper and electronic files for secure ongoing storage and for easy recall upon request. The role will support the organization, indexing and verification of documentation before it is sent to clients. Responsibilities also include:
- Facilitate changes to SOPs, policies, training materials and other documents as needed.
- Manage the process of storing and archiving records for the GMP operation.
- Own and ensure that the document management storage and archiving process used in QA is properly maintained, executed, measured and improved.
- Manage, organize and maintain Prolytix’s records and storage room as well as electronic records kept for storage and archiving.
- Support and participate in regulatory inspection/customer audit processes to ensure requested documents are readily and promptly available.
- Ensure that stored/archived records are managed in accordance with Prolytix’s internal document retention guidelines, including secure storage, indexing and destruction of documents when their retention period expires.
- Actively work with Quality Specialists and customers to dispose and destroy records as required.
- Review and organize data (Certificates of Analysis) sent to customers, including but not limited to QC test data, method qualification and validation data, clinical data entered into data transfer
- Other assigned tasks.
- Associate’s degree in or related field
- 3 to 5 years of experience
- Excellent written and oral communication skills.
- Strong organizational skills with the ability to work independently and in a team, and multi-task
- Cross-functional experience working across multiple departments in an organization
- Experience working with quality systems in a GMP environment.
- Demonstrated communication and collaboration skills to effectively provide training and coaching for quality processes, brief management on key issues and risks.
- Attention to detail
- Analytical, critical thinking and problem solving skills to examine systems, find flaws and propose solutions
- Experience with Master Control an asset.
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Prolytix, formerly Haematologic Technologies (HT), is a leading provider of analytical and bioanalytical services to support the research, development and commercialization of large molecule biotherapeutics and reagents for coagulation research. Prolytix draws on over 30 years of expertise to identify and solve the most complex large molecule problems. Prolytix’s expertise in protein biochemistry supports biotherapies from discovery to commercialization, with biopharmaceutical services all performed in fully GMP compliant and FDA inspected facilities. The company also provides expertise in plasma proteins, hemostasis and blood coagulation and is one of the world’s leading suppliers of coagulation research reagents (plasma protein and antibodies), reagents for IVD/POC devices formulated on measurement, as well as custom blood collection tubes to support clinical trials. . Visit us by clicking the web link icon above.
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