NewarkRecruiter Since 2001
the smart solution for Newark jobs

Technical Writer - GMP Documentation & Batch Records - QA

Company: Tech Observer
Location: Newark
Posted on: October 18, 2020

Job Description:

This is a contract opportunity for Technical Writer - GMP Documentation & Batch Records - QA located in East Hanover, NJ Duties: Assists on authoring developmental protocols and reports, as necessary. Creation and revision of GMP documentation including Production Batch Records, Standard Operating Procedures, and related documentation. Coordination of timelines, document revisions and review cycles for all GMP documents including delegation to the appropriate groups for review to ensure timely production start dates. Driving the continual improvement of GMP Batch Records and SOPs between review cycle by soliciting and incorporating feedback from Analytical & Process Science, Engineering, and Quality groups. Review of completed batch records and other GMP documents in collaboration with Quality Assurance as needed to ensure accuracy and completion in accordance with cGMP regulations. Supports preparing Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification documents/programs. Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Company Policies. Skills: Knowledge of biopharmaceutical unit operations for production of cell therapies is preferred. Qualification experience or applicable experience in a related area in the Pharmaceutical industry. 5+ years of Pharmaceutical industry experience and 5 + years of Facilities, Utilities, Equipment and Analytical Instruments. 3+ years of experience in a GMP environment or relevant GMP documentation experience. Proficiency in standard word processing software and project management software is required. Mandatory professional skills including knowledge of cGMPs for biopharmaceuticals, organized and disciplined record keeping, excellent communication skills, an ability to work effectively with others in a dynamic environment, and the ability to self-motivate, multitask, and meet tight deadlines. Education: Bachelor's degree in Scientific discipline or other related field with significant prior experience or equivalent.

Keywords: Tech Observer, Newark , Technical Writer - GMP Documentation & Batch Records - QA, IT / Software / Systems , Newark, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other IT / Software / Systems Jobs


Big data Hadoop developer/ Architect- contract
Description: If interested, please reach out to Iram Shah 203-770-0936 Please note This role is for a senior expert level candidate. The interview process is extremely rigorous. Location Remote for now. NYC after
Company: Nutech Information Systems
Location: New York
Posted on: 10/26/2020

Business Intelligence- SQL Developer
Description: As Business Intelligence BI T-SQL Developer, you will play a key role in the maintenance and further development of a high-volume ticketing system powering some of Philadelphia s most renowned nonprofit (more...)
Company: The Philadelphia Orchestra
Location: Philadelphia
Posted on: 10/26/2020

Citrix Developer
Description: Citrix DeveloperPosition Location Maryland 7 years of application configuration administration experience bull Familiarity with Citrix XenApp and StoreFront
Company: Insap Services, Inc.
Location: Marlton
Posted on: 10/26/2020


Sr. Python Developer only NY/NJ
Description: Hello, Job Title Sr. Python Developer Location NYC, NC Duration Contract Job descriptions
Company: SUNRAY INFORMATICS
Location: New York
Posted on: 10/26/2020

Entry Level Software Engineer
Description: Job DescriptionAs a leader in recruiting emerging technology talent across the country, Revature is looking forward to hiring over 300 new Entry Level Software Engineers in the next 4 weeks. One day someone (more...)
Company: Revature
Location: Reading
Posted on: 10/26/2020

Senior Technical Product Manager, Mobile & CTV
Description: Who we are: br br DoubleVerify is the leader in digital performance solutions, improving the impression quality and audience impact of digital advertising. Built on best practices, DoubleVerify solutions (more...)
Company: DoubleVerify
Location: New York
Posted on: 10/26/2020

Product Owner, Platform Software and Tooling
Description: POSITION SUMMARY: br br Zoetis has created a new Data and Digital Platform DDP team that is driving a step change in the company s ability to harness data, particularly data generated by the expanding (more...)
Company: Zoetis, Inc.
Location: Parsippany
Posted on: 10/26/2020

Cable Installation Technician
Description: Veteran Firm Seeking Cable Installation Technicians for Roles in New York City, NY br br My name is Stephen Hrutka and I am the owner of a Veteran-owned firm in Washington, DC focused on Supply Chain, (more...)
Company: HRUCKUS
Location: New York
Posted on: 10/26/2020

Python Developer w AWS & REST
Description: Skills Client is Looking for Python and SQL AWS MUST HAVE AND should have deep understanding of REST, service architecture. br br br br br Python Developer br br We are a digitally native (more...)
Company: Yoh, A Day & Zimmermann Company
Location: East Elmhurst
Posted on: 10/26/2020

Software Developer (No Prior Experience Required)
Description: Revature will hire over 300 new Software Developers in the next 4 weeks. As the largest employer of emerging tech talent, we are looking for candidates all around the U.S.One day someone is going to ask (more...)
Company: Revature
Location: Elizabeth
Posted on: 10/26/2020

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Newark RSS job feeds