- 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).
- 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 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.
- 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 cGMP's 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, Associate's or Bachelor's Degree with emphasis in science or technical writing preferred.
-
Document Control Specialist
1 week ago
Bove Industries, Inc East Setauket, United States**Responsibilities** · - Understanding of current minority participation program requirements. · - Answer inquiries and route messages to staff · - Compose and/or edit letters, memos, reports, etc., as required · - Procure and track both paper and digital documents for bidding an ...
-
Document Control Specialist
21 hours ago
Actalent Stratford, United States Full timeDescription: · Pre-production preparation, review, and approval of batch records for various cGMP OTC, medical device, and pharmaceutical products · Post-production batch record review and approval · Review production data and draft COA and COC from this data using approved templ ...
-
Document Control Specialist
18 hours ago
Country Life Hauppauge, United StatesAt 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, N ...
-
Document Control Specialist
3 days ago
Country Life Hauppauge, United StatesAt 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, N ...
-
Specialist Control Engineering
2 weeks ago
Emerald Enterprises New Hyde Park, NY, United States FreelanceYOUR NEXT STEP IN AN INTERNATIONAL CORPORATION · - Exciting opportunities and development possibilities at the BMW Group location in Dingolfing. · You will work independently on a BMW vehicle project. In doing so, you will plan and implement the control and electrical functions o ...
-
Logistics specialist with a focus on control
1 week ago
Titan Ventures Fairfield, United StatesLogistics Specialist with a focus on control (m/f/d) in Fairfield Full-time We celebrate challenges, do you want to join us? Come to Rent.Group Munich as a Logistics Specialist with a focus on control (m/f/d) and test your skills in logistics Tetris. Logistics Specialist with a f ...
-
Pest control specialist starting at 3100 euros
2 weeks ago
Cascade Enterprises Glen Cove, NY, United States FreelanceWe are currently seeking to strengthen our team at a family-run, rapidly growing company with a regional presence in Glen Cove, NY. We are looking for an IHK certified pest control specialist (m/f/d) with partial expertise according to TRGS 523 (m/f/d). · Join our success story i ...
-
Air Traffic Control Specialist
16 hours ago
Federal Aviation Administration Ronkonkoma, United StatesSummary · Serves as the Traffic Management Coordinator at a level 12 enroute facility. Works under the administrative supervision of the Supervisory Traffic Management Coordinator. · Duties · Ensures that traffic management instructions/restrictions are initiated in accordance ...
-
IT system engineer for IT security
1 week ago
Infinity Enterprises Smithtown, United StatesAbout the Company · We are one of the leading providers nationwide for the planning, implementation, and support of IT infrastructures, managed services, and cloud solutions in Smithtown. · What We Offer · Attractive, performance-based salary model · Permanent employment contract ...
-
Remote Pilot Operator at Zny
1 week ago
SAIC Ronkonkoma, United StatesJob ID: · **Location**:RONKONKOMA, NY, US · **Date Posted**: · **Category**:Information Technology · **Subcategory**:Computer Operator · **Schedule**:Full-time · **Shift**:Day Job · **Travel**:No · **Minimum Clearance Required**:None · **Clearance Level Must Be Able to Obtain** ...
-
Process Manager
1 week ago
Phoenix Industries Nesconset, United StatesProcess Manager (m/f/x) About Us Our colleagues transport millions of people in Bavaria and Baden-Württemberg in the most modern trains to work, the mountains, or to friends. We are convinced of the relevance of the railway to achieve our climate goals. Our "we can do it" mentali ...
-
Building technology
2 weeks ago
Crimson Technologies Commack, NY, United States Freelance**Facility Technician (m/f/d € Welcome Bonus - Commack, NY** · **What you bring:** · - You have completed training as a plumber and heating installer. · - You have experience in heating, ventilation, air conditioning, electrical engineering, and operating control systems. · - You ...
-
Eclipse Enterprises Commack, United StatesAs the leader of our team, you will be responsible for organizing the safe and timely delivery of partial and full loads, whether it be with articulated trucks, Euro and Megatrailers, or standard trucks. You will also be responsible for managing and leading the existing team. Add ...
-
Electrical Controls Specialist
3 weeks ago
Bimbo Bakeries USA Greenwich, United States Full timeElectrical Controls Specialistreq36990 · Employment Type: Regular Location: GREENWICH,CT Have you ever enjoyed Arnold, Brownberry or Oroweat bread? A Thomas English muffin or bagel? Or perhaps snacked on a Sara Lee, Entenmanns or Marinela cake or donut? If the answer is yes, the ...
-
Pest Control Specialist
2 days ago
Insight Pest Solutions LLC Milford, United StatesJob Description · Job Description$4,000.00 BONUS TO NEW HAMPSHIRE F1 PEST LICENSE HOLDERS · $4,000 BONUS AWARDED TO THOSE THAT CAN PASS THE NH PESTICICIDE TEST ON FIRST TRY · INSIGHT PEST SOLUTIONS · Equal Opportunity Employer · All qualified applicants are encouraged to apply, ...
-
Cost Controls Specialist
3 weeks ago
Smart Ims Fairfield, United States Full timeCompany Description · Smart IMS delivers IT solutions and services that create a sustainable competitive advantage for its clients across the world. The company was founded by business and technology experts with extensive backgrounds in designing, implementing, and managing larg ...
-
Surveying Technician
1 week ago
Titan Ventures Head of the Harbor, United States**About IPW Ingenieurplanung GmbH & CO. KG:** · Motivation, enthusiasm, reliability, and customer proximity - these are the qualities that describe one side of our work. It is creativity and added value that are often priceless in tasks in the public space. Experience, expertise, ...
-
Senior Control Tower Specialist
1 week ago
DSV Air & Sea Valley Stream, United StatesIf you are a current DSV employee and interested in a position in another country,please contact your Human Resource representative to discuss the process and requirements of applying. · Job area: Customer Service · DSV - Global transport and logistics · In 1976, ten independent ...
-
Youth Support Specialist
4 days ago
NYS Office of Children and Family Services Dix Hills, United States**Minimum Qualifications**: · Two years full-time direct care experience* in the care and programming of youth** under 21 years of age; · OR two years of full-time experience in the care, programming and/or secure custody of residential clients in a health care, mental hygiene or ...
-
Crimson Solutions Dix Hills, United StatesDual Training as an IT Specialist for System Integration at Dix Hills · Your Dual Training at DFS · Do you know the difference between software and hardware? When your computer doesn't react as expected, do you feel challenged to find a solution instead of getting frustrated? The ...
Document Control Specialist - Hauppauge, United States - Country Life
3 days ago
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 company's 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:
