Documument Control Specialist
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.
• Manages electronic files of SOP's, 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 SOP's. 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 SOP's, 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 cGMP's 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).
• Coordinates with outside facilities to create Plant Master Files for various countries as required, in accordance with each country's guidelines.
• Issues master production batch records to the manufacturing department according to the production schedule and special requests from the manufacturing department.
• Reviews new master production batch records as they come from the formulator and notifies formulator of any discrepancies. • Periodically updates the production schedule for manufacturing department.
• Tracks the issuance of deviations to ensure FDA compliance and reports to Regulatory Affairs department as requested.
• Release from QA finished products that are manufactured and/or packaged by an outside vendor. Keep and update log books and C of A's for items released. Labels and stores retention samples for released items.
• Prepares samples of finished products that are manufactured and/or packaged by an outside vendor. Sends samples to various outside labs to be analyzed. Maintains and updates log books for samples sent. Ensures that C of A's are sent to QA from the lab in a timely manner and files the C of A's when received.
• Coordinates in-house training for 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.
• Performs warehouse transfers of items from outside vendors after they are released from QA. Prints out Inventory reports to assess what is on hold.
Notifies, by email, the Purchasing department when a vendor needs to be contacted concerning a raw material or finished product error.
• Maintains and updates Customer complaint laboratory results and notifies the Regulatory department of its findings.
• Creates daily list of products that are currently on hold in the manufacturing and packaging departments.
• Provides copies of formulas for Regulatory as needed. • Contacts exterminator when needed. Tracks visits and collects and files reports and MSDS from technician. Lead o Reviews and approves time sheets. o Advises Supervisor with any performance issues. o Ensures daily work flow completion.
• 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 Administration's 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. Experience and Skills:
• Working knowledge of controlled document system required, FDA cGMP's preferred.
• Comprehensive knowledge and high degree of skill in MS Word with 2 years experience in word processing. Working knowledge of MS Office, including Excel, Outlook and working with mainframe systems.
• Well organized and detail oriented.
• Good verbal and excellent written communication skills.
• Ability to work in a team environment with good interpersonal skills.
Since our founding in 1971, we have always been passionate about providing you with the opportunity to achieve great health. Throughout our 40+ year history as a leader in the natural health industry, we',ve reached a number of milestones in the pursuit of helping you reach a healthier, happier you.
Fri, 21 Apr 2017 11:13:53 PDT