- Coordinate the activities of Document Control, including the tracking, release, distribution, and auditing of controlled documents.
- Organize and facilitate approval process of Change Orders, including distribution and archiving of final documents whether hard copy or electronic.
- Review completeness of documentation for accuracy and consistency.
- Maintain compliance activities associated with the Quality Management System (QMS) to comply with applicable regulations.
- Reviewing completeness and processing of deviations.
- Collaborate with subject matter experts effectively to prepare controlled documents per our GDP procedures.
- Managing GTIN Database.
- Compilation of monthly document control metrics.
- Effectively follow SOPs, policies, and FDA Good Manufacturing Practices.
- Provides support for the Quality Systems and Regulatory departments during internal and external audits and actively participate in department activities.
- Support the CAPA program as needed.
- Scan, file and/or box documentation (, batch records, Special Request etc.) and verify documentation for destruction, per our established procedure as applicable per site.
- Maintaining External Standards and processing of requests for updates or new purchases
- Perform other duties as assigned.
- Assist in technical projects as needed.
- High School Diploma or equivalent
- 3+ years' experience within Document Control
- Related experience working with Quality System or technical documentation systems, preferably in an FDA regulated environment
- Working knowledge of ISO and FDA document management guidelines, regulations, and standards
- Outstanding attention to detail
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
- Ability to utilize multiple word-processing and database applications including MS Office applications Word, Excel, and other software applications as necessary
- Bachelor's degree preferred
- Ability to work independently
- Type 45 WPM
- Excellent Customer Service
- Problem solving Skills
- Prior knowledge and experience with electronic document management systems (DMS), learning management systems (LMS), product lifecycle management systems (PLM) or enterprise resource planning systems (ERP) is preferred
- This position requires frequent or continuous sitting and/or standing.
- This position requires frequent or continuous walking.
- This position requires frequent or continuous moderate lifting of 15-40lbs.
The anticipated base hourly rate for an employee who is located in California this position is $ to $ per hour, plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations. -
Multinational Credit Control Specialist
1 day ago
Chubb INA Holdings Inc. Glasgow, United KingdomDo you have a Credit control background from within a global organisation? · If interested in growing your skills and career within one of the largest commercial insurers in the world, then we would love to hear from you · The main purpose of this role is to take full ownership o ...
-
Credit Controller
5 days ago
Access Plus Scotland Ltd Irvine, United Kingdom**Credit Controller** · Access Plus is a powered access equipment hire company delivering specialist solutions throughout the UK. We are currently looking to recruit an experienced and dynamic Credit Controller to join our team at our Irvine HQ in this critical role. · Reporting ...
-
Industrial Hygienist
2 days ago
GSK Irvine, United Kingdom**Site Name**: UK - North Ayrshire - Irvine · **Posted Date**: Apr · We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and r ...
-
Hygiene Chargehand
1 day ago
Dunbia Saltcoats, United KingdomOverview: · As part of a successful Management team this is a hands-on role reporting to the Food Safety and Quality Manager. · The role holder will be responsible for providing a service to the operational team, that ensures all aspects of the daytime hygiene activities are mana ...
-
System Administrator
1 day ago
NHS Scotland Kilmarnock, United KingdomAn exciting opportunity has arisen for the post of System Administrator within the Digital Services Programme Team. · You will provide a comprehensive system help and support service or appropriate Digital Systems. · Use the management functions of the systems to control access, ...
-
Senior Project Control Specialist
17 hours ago
Sustainable Talent LTD Motherwell, United KingdomSenior Project Controls Specialist - Renewables and Energy sector · LOCATION: Motherwell, Scotland · The right candidate will need to have the following: · Primavera P6, MSP and other project control methodologies experience · Strong H&S awareness · Experience of building, develo ...
-
Senior Project Control Specialist
5 hours ago
Sustainable Talent LTD Motherwell, United KingdomJob Description · Senior Project Controls Specialist - Renewables and Energy sector · LOCATION: Motherwell, Scotland · The right candidate will need to have the following: · Primavera P6, MSP and other project control methodologies experience · Strong H&S awareness · Experience o ...
-
Document Controller
4 days ago
Wates Dalry, United KingdomSES Engineering Services are looking for a Document Controller to join our team in Ayrshire, focussing on high profile, technically complex mechanical and electrical projects across multiple sectors. · If you are passionate about supporting our onsite teams and looking for an opp ...
-
Facilities Management Services Coordinator
5 days ago
Mitie Prestwick, United Kingdom**Facility Management Services Coordinator (FMSC)** · **Responsible To**:Operations Manager** · **Location: NATS Prestwick**: · **Subordinates: None**: · **Principle Accountabilities**: · - Administration of subcontractor callout (normal and emergency) and subsequent service docu ...
-
Supply Chain Summer Student
5 days ago
Collins Aerospace Prestwick, United Kingdom**Date Posted**: · **Country**: · United Kingdom · **Location**: · Rohr Aero Services Limited, 1 Dow Avenue, Prestwick International Aerospace Park, Prestwick, KA9 2SA · **Position Role Type**: · Unspecified · **SUPPLY CHAIN - SUMMER STUDENT PLACEMENT** · Collins Aerospace, a Ray ...
-
Finance Business Support Partner
4 days ago
Collins Aerospace Prestwick, United Kingdom**Date Posted**: · **Country**: · United Kingdom · **Location**: · Rohr Aero Services Limited, 1 Dow Avenue, Prestwick International Aerospace Park, Prestwick, KA9 2SA · **Position Role Type**: · Unspecified · Collins Aerospace, a Raytheon Technologies company, is a leader in tec ...
-
Supplier Quality Engineer
17 hours ago
Verify Europe Prestwick, United Kingdom Full timeWe are looking for 1 X experienced Supplier Quality Engineers for our Aerospace Customer. · This is a 5 month contract role in Prestwick which will be working entirely on-site, with no working from home. · 37 hours per week, over 5 days with an early finish on a Friday. · The rol ...
-
Sanderson Recruitment Plc Glasgow, United Kingdom FreelanceThis role must be via an Umbrella and will be Glasgow - Hybrid Once/Twice per week to Office. · Location: Glasgow - Hybrid Once/Twice per week to Office · Ensure all project documents are managed in line with procedures, following QA checking of receipted Documents. · Issue an ...
-
Production Manager
3 days ago
Rise Technical Recruitment Limited Ayr, United Kingdom Full timeCHP Manager · Ayr, commutable from: South Glasgow, Renfrew, Paisley, Johnston, Barrhead, Giffnock, Newton Mearns, East Kilbride, Saltcoats, Irvine, Kimarnock & all surrounding areas · Extremely Competitive Salary + Excellent Company Benefits · Do you have supervisory or manageria ...
-
Ssd Co-ordinator
1 day ago
NHS Scotland Glasgow, United KingdomThe Scottish Ambulance Services' Specialist Services Desk is based within the West Ambulance Control Centre in Glasgow. We co-ordinate the use of Air Ambulance assets, Trauma Teams and Specialist Retrieval Teams (ScotSTAR) for Scotland. We are the logístical epicentre of Speciali ...
-
Senior Cost Controller
4 days ago
Doosan Babcock Renfrew, United Kingdom**Senior Cost Controler**: · The Asset Management function within Altrad Babcock is a highly specialised engineering service and equipment provider supporting our customers to minimise cost, maximise return and mitigate risk through their asset's integrity lifecycle. · The Projec ...
-
Planner
3 days ago
Doosan Babcock Renfrew, United Kingdom**Job Information**: · Altrad Babcock are experts in providing engineering solutions from new build projects to upgrades, retrofits and specialist professional services to the energy and process sectors including the pharmaceutical, oil, gas and chemicals industries. Our clients ...
-
Senior Credit Controller
4 days ago
SThree Internal Glasgow, United Kingdom**Senior Credit Controller**: · **Job reference no**: VN12163 · **Job type**: Permanent · **Location**: Glasgow, Scotland, United Kingdom · We're delighted to share that we're recruiting for a **Senior Credit Controller** to join our brilliant team · The Senior Credit Controller ...
-
Infrastructure Support Specialist
5 days ago
Bermuda Monetary Authority Hamilton, United Kingdom**Description**: · **Infrastructure Support Specialist** · **Management Services Department** · Bermuda Monetary Authority (BMA or Authority) is seeking the services of a qualified and experienced individual to work as an Infrastructure Support Specialist within the Management Se ...
-
Senior Finance Manager
2 days ago
Advanced Resource Managers Limited Helensburgh, United KingdomSenior Finance Manager - Helensburgh (Hybrid) - Permanent - £Negotiable · ARM are delighted to be recruiting for a Senior Finance Manager to join one of their top Defence clients in Helensburgh on a permanent basis · **Requirements**: · - Proven experience in a Senior Finance rol ...
Document Control Specialist - Irvine, United Kingdom - Orthofix
4 days ago
Description
Why Orthofix?
We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning
Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun
How you'll make a difference?
As a subject matter expert, the Document Control Specialist will coordinate document control activities related to the document management and data management systems. This position is also responsible for interfacing with all departments to organize, maintain and edit documentation in support of products and quality system processes.
What will your duties and responsibilities be?
What skills and experience will you need?
Education/Certifications:
Experience, Skills, Knowledge and/or Abilities:
What qualifications are preferred?
Education/Certifications:
Additional Experience, Skills, Knowledge and/or Abilities:
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
DISCLAIMER
