The Document Specialist is responsible for the management of the documents and records in both hard 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 the organization, storage and archiving of all paper-based and electronic documentation. The role will be responsible for indexing and organizing paper and electronic files for secure ongoing storage and for ease of recall upon request. The Sr. Documentation Specialist role is available for well qualified candidates. The role will support the organization, indexing and checking of documentation prior to sending to clients.
- Facilitate changes to SOPs, policies, training materials, and other documents as needed.
- Manage the records storage and archiving process for the GMP operation.
- Own and ensure the document management storage and archival process used in QA is properly maintained, executed, measured and improved.
- Manage, organize and maintain the Prolytix archive and storage room as well as the electronic records maintained for storage and archival.
- Support and participate in the regulatory inspection/ customer audit processes to assure requested documents are readily and quickly available.
- Assure stored / archived records are managed to the Prolytix internal document retention guidelines, including secured storage, indexing, and destruction of documents upon expiration of their retention period.
- Actively work with Quality Specialists and clients to disposition and destroy records as required.
- Review and organize data (Certificates of Analysis) sent to clients, including but not limited to QC Test data, method qualification and method validation data, clinical data entered into Data transfer forms
- Other duties as assigned.
Education and Experience
- Associates degree in, or a related field
- 3-5 years’ experience
- Excellent written and oral communication skills
- Strong organizational skills with ability to work independently and in a team, and multi-task
- Cross-functional experience working across 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, update Management on key issues and risks
- Attention to detail
- Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions
- Experience with Master Control a plus
- Strong basic math skills with emphasis on data entry (alpha numeric), and common scientific calculations.
- Strong basic statistic skills. Required Statistic skills include calculations of Means, standard deviations, percent error as well as probabilities.
- Basic understanding of ICH, FDA, and EMA regulatory and/or guidance documents as well as US and international pharmacopeia, as related to quality assurance activities.
- Ability to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change.
- Ability to multi-task and adjust to changing deadlines.
- Ability to work independently and in a team-based environment.
- Intermediate to advance level knowledge in Microsoft Office and Adobe applications.
- The Documentation Specialist, QA reports to the Manager, GMP QA.
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 builds on 30+ years of expertise to identify and solve the most complex large molecule challenges. Prolytix’s expertise in protein biochemistry supports biotherapeutics from discovery through commercial release, with biopharma services all performed in fully compliant, FDA-inspected GMP facilities. The company also provides expertise in plasma proteins, hemostasis, and blood coagulation and is a leading global supplier of coagulation research reagents (plasma proteins and antibodies), custom formulated IVD/POC device reagents, as well as customized blood collection tubes to support clinical trials. Visit us at goprolytix.com.