QA Specialist (Document Control)
Durham, United States
Posted on: January 14, 2021
Closing: February 13, 2021
Position Type: Full Time
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in Japan and the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.
The QA Specialist/Document Control is responsible for ensuring the BioCryst Document Control System is maintained in compliance with BioCryst’s SOPs and Quality Systems, and for coordinating and managing the review of GMP documents to support external manufacturing. Reporting to the QA Manager, this position is responsible for administering the Document Control systems to ensure compliance to applicable internal procedures, cGMPs, and regulatory requirements. This position will also be responsible for assisting with administration of the BioCryst training program related to the controlled documents and internal training. Functions include QA support for document control, and training. In addition, this position will be responsible for tracking and facilitating the timely receipt, review, and approval process of GMP documents with external manufacturing partners.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Under the direction of the QA Manager, works to administer effective Document Control systems ensuring compliance to applicable internal procedures, cGMPs, and regulatory requirements.
- Serves as Document Control/EDMS administrator.
- Supports review, update, filing and distribution of controlled documents, including standard operating procedures, standard test methods, protocols, summary reports, and technical documents according to specific Document Control format standards and guidelines.
- Creates and maintains controlled document templates.
- Ensures controlled documents conform with applicable procedures and are maintained to latest revisions; reviews formats for consistency.
- Responsible for timely distribution of draft and final controlled documents.
- Coordinates the approval process and orderly upload and filing of controlled documents to SharePoint.
- Supports controlled document life cycle/retention procedures.
- Assists with Biennial Review and Document Change Control Programs.
- Performs proofreading, editing, word processing, and filing to support Quality Assurance Documentation.
- Creates and maintains filing systems (electronic and paper) for all controlled documents.
- Organizes and maintains QA Document Room and Batch Release documentation relative to projects.
- Maintains Master Content Lists and Tracking Sheets for SOPs, Policies, Test Methods, and document number issuance logs for controlled documents.
- Assists with paper and electronic Records Retention/Archiving, ensuring adherence to specific records retention schedules.
- Under the direction of the QA Manager, supports the GxP training program.
- Assists with employee Training Program and periodic review of all training files.
- Assists with Training Matrix updates for all employees, and maintenance of employee electronic training files.
- Back-up administrator for ComplianceWire Organization Administrator
- Coordinates and manages the Document Processing function to support GMP manufacturing activities at external vendors.
- Serves as the primary point of contact for GMP documents in the review/approval process. Regularly monitors Document Processing email for incoming documents for review.
- Initiates review of document using appropriate system (paper or electronic based). Sets due dates for various stages of review process.
- Coordinates with CMC Project Management on expected document receipt, review, and approval timeframes.
- Establishes required document reviewers in coordination with Project Management, CMC, and Quality Assurance. Requests review/approval timeframe expectations from document owner if not provided upon document receipt.
- In coordination with document reviewers and Project Manager, identifies resource conflicts for document review and promptly notifies Supervisor of such conflicts.
- Monitors the review process closely by maintaining frequent interaction with document reviewers/approvers and document owner (sender) to ensure that reviews are completed on time.
- Initiates discussion between reviewers as needed to resolve comments/questions.
- Collates comments/questions into electronic document, forwards to document owner and follows up as needed on receipt of corrected document and/or response to comments.
- Coordinates final review and approval signature(s).
- Files fully executed document in the appropriate location OR provides fully executed document to appropriate personnel.
- Organizes documentation in electronic systems.
- Assists with document retrieval for internal audits and regulatory inspections.
- Provides cross-functional support within QA department, as needed.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Maintains an awareness of evolving industry standards for document generation and electronic document management.
- All other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
- Minimum Associate Degree or equivalent, prefer a Bachelor degree.
- 0-2 years of experience (with Bachelor degree) or 2-3 years of experience (with Associate Degree) in document processing/document management in a biotech, pharmaceutical, or contract research organization highly preferred
- Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word. Excel, PowerPoint, One Drive, SharePoint.
- Ability to work under pressure with tight deadlines.
- Ability to maintain confidentiality and work with sensitive documents.
- Interpersonal skills - ability to interact well with colleagues at all levels.
- Adapts to changing priorities effectively.
- Knowledge of FDA regulations and industry standard guidelines for electronic records; i.e., 21 CFR Part 11.
- Demonstrate ethical conduct, focus on goals, take ownership of actions, and act in the best interest of the Company.
- Knowledge of US FDA and European GMP requirements and associated guidelines.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Posted on: January 14, 2021
Closing: February 13, 2021
Position Type: Full Time