- Manages electronic files of SOPs, including their names, locations, and revision histories on the network file server.Revision histories are tracked on a spreadsheet located on the server.
- Maintains documents in accordance with department SOPs.Analyzes all documents to ensure that controls regarding format and content are incorporated.
- Provides copies of documents as required and manages the Copy Control system. This includes tracking locations of copies of certain selected documents and replacing obsolete copies with new revision copies.
- Works with management from various departments (Production, Regulatory Affairs and Quality) to plan and prioritize projects (e.g., new SOPs, new equipment, new vendors, validations, new products). Advises department heads as to conflicting priorities which impact Documentation Control.Reports to Director of Quality when the proposed changes may indicate non-compliance.
- Maintains database of information including all document numbers, dates and distribution requirements. Generates logs, indexes and distribution lists as required.Assures that all documents are reviewed for continuing compliance to cGMPs and company policies on a periodic basis.
- Processes change control activities includes assigning tracking numbers, routing, tracking, and expediting change control packages, distributing new documents and retrieving obsolete ones, performing changes to text documents, and reporting on change control status to management.
- Maintains Quality Group documents, including Certificates of Analysis (C of A), Master Batch Records (MBR) and Master Material Records (MMR).
- Issues master production batch records to the manufacturing department according to the production schedule and special requests from the manufacturing / planning departments.
- Reviews new master production batch records as they come from the formulator and notifies formulator of any discrepancies.
- Tracks the issuance and closure of deviations to ensure FDA compliance.
- Communicates issuance of new and revised documents as required. Maintains hardcopies and electronic database of all employee training records.
- Notifies, by email, appropriate departments when a product/raw material/label is rejected by QA. Takes pictures of rejected products as needed and fills in and sends out rejection notices.
- Creates daily list of products that are currently on hold in the manufacturing and packaging departments.
- Contacts exterminator when needed. Tracks visits and collects and files reports and MSDS from technician.
- Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.
- Satisfactory completion of appropriate corporate training as related to the position and/or department.
- Assures compliance by following Food and Drug Administrations Good Manufacturing Policies as well as other regulatory standards as required by the department.
- Contributes to overall achievement by accomplishing related tasks and demonstrating characteristics that exemplify team building and support.
- The above is not intended to be an all-inclusive list of responsibilities.Other activities may be assigned as required by management.
- Oversees 1-2 direct reports including compliance auditor.
- Reviews and approves time sheets.
- Advises Supervisor with any performance issues.
- Ensures daily work flow completion.
- Working knowledge of controlled document system required, FDA cGMPs preferred.
- Comprehensive knowledge and high degree of skill in Microsoft Office including Excel, Word, Outlook, and Power Point.
- Well organized and detail oriented.
- Good verbal and excellent written communication skills.
- Ability to work in a team environment with good interpersonal skills.
- High School Diploma required, Associates or Bachelors Degree with emphasis in science or technical writing preferred.
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Document Control Specialist - Hauppauge, United States - Country Life
Description
At Country Life, we inspire greatness through our wholistic approach of supplement and personal care products. Our team of experts, innovators and dreamers is dedicated to bringing the power of nature and the promise of science to people at every life stage. Join our Hauppauge, NY team and share our passion for natural health and pride in our companys commitment to excellence and quality
Position Summary: To comply with Food & Drug Administration (FDA) Good Manufacturing Practices (cGMPs), will maintain corporate Standard Operating Procedures (SOPs), component specifications (excluding labeling), Master Batch Records, analytical reports, deviations, change control and other formally controlled documents within the company. Performs all the documentation control activities for document system including releasing new documents, processing change control and related forms, copy control, maintaining electronic files on the network file server, tracking document revision histories, and archiving obsolete documents.
Position Responsibility:
Supervisory
Experience and Skills:
Education and Certifications:
