Highlights
Job Title: Quality Control Documentation Specialist Location: Portsmouth, NH, 03801 Duration: 8 Months Job Type: Temporary Assignment Work Type: Onsite Summary The Documentation Specialist is responsible for maintaining QC chemical raw material specifications through the Document Management System (DMS) and Laboratory Information Management System (LIMS). Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases.
Numbers & Facts
| Location | Portsmouth, NH |
| Industry | Computer/IT Services |
| Salary | $30–$35 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Job Title: Quality Control Documentation Specialist
Location: Portsmouth, NH, 03801
Duration: 8 Months
Job Type: Temporary Assignment
Work Type: Onsite
Summary
The Documentation Specialist is responsible for maintaining QC chemical raw material specifications through the Document Management System (DMS) and Laboratory Information Management System (LIMS). The role supports specification accuracy and functionality for site production while working with Raw Material Scientists, Coordinators, and cross-functional stakeholders. The position requires knowledge of compendia (USP, EP, etc.), computerized management systems, Microsoft Suite, data integrity principles, and cGMP awareness.
Responsibilities
- Manage updates to raw material specifications requested through compliance records, management requests, or other points of entry.
- Collaborate with Raw Material Scientists and Coordinators to provide useful testing specifications.
- Communicate clearly with cross-functional stakeholders and raw materials team members regarding specification changes.
- Own specification documents and relevant SOPs and Work Instructions (WIs), as applicable.
- Apply Data Integrity principles in accordance with Lonza DI policies, guidelines, and procedures.
- Create and update LIMS templates for new and existing raw material specifications.
- Perform other duties as assigned.
Required Skills & Qualifications
- Associate's degree in Science preferred/required; a combination of education and years of experience will be considered.
- 0 4 years of experience; minimum 2 years of editing and/or regulated industry experience.
- Advanced proficiency in Microsoft Office Suite, particularly Word and Excel.
- Excellent proofreading and editing skills.
- Experience with Document Management Systems (DMS) and document control practices.
- Experience with document change management.
- Experience in technical writing, including protocols, reports, specifications, and methods.
- Knowledge of LIMS and computerized management systems.
- Knowledge of compendia, including USP and EP.
- Awareness of cGMP requirements.
- Understanding and application of Data Integrity principles.
- Ability to effectively interpret written and verbal instructions.
- Strong communication and collaboration skills.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.