Technical Writer QC Validation
Apply NowCompany: US Pharma Lab
Location: North Brunswick, NJ 08902
Description:
Job Description
Date
02/2021
Location
1200 Airport Road, North Brunswick NJ
Title
Validation Technical Writer
Department
Quality Control
Reports to
Vice President, Quality Control
FLSA (Exempt or Non-Exempt)
Non-Exempt
Role Overview
As the Validation Technical Writer, you are coordinating validation and technology transfer activities and provide guidance and technical advice to analytical staff in written and oral communications. Functions will include supporting Laboratory investigations and writing technical validation protocols, validation reports for method qualifications/transfers/verifications, stability protocols & reports as it pertains to raw materials and finished products from provided analytical data. Other functions include test method, specification, and other analytical documentation writing activities.
Areas of Responsibility
Comply with all job-related safety and other training requirements.
Requirements
Education & Qualification:
Certifications, Licenses, Credentials:
N/A
Skills & Ability
Physical Requirements (Lifting, etc.):
Work Environment (Office, Warehouse, temperature extremes, etc.):
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
Date
02/2021
Location
1200 Airport Road, North Brunswick NJ
Title
Validation Technical Writer
Department
Quality Control
Reports to
Vice President, Quality Control
FLSA (Exempt or Non-Exempt)
Non-Exempt
Role Overview
As the Validation Technical Writer, you are coordinating validation and technology transfer activities and provide guidance and technical advice to analytical staff in written and oral communications. Functions will include supporting Laboratory investigations and writing technical validation protocols, validation reports for method qualifications/transfers/verifications, stability protocols & reports as it pertains to raw materials and finished products from provided analytical data. Other functions include test method, specification, and other analytical documentation writing activities.
Areas of Responsibility
- Authorship of analytical validation/qualification/technical transfer/verification protocols based on applicable validation regulations and relative guidance documentation.
- Authorship of stability protocols based on applicable ICH guidelines and FDA regulations and relative guidance documentation.
- Authors final reports of validation/qualification/technical transfer/verification protocols from all types of applicable data, raw data from protocol executions, and electronic records generated during protocol execution.
- Authors of test methods, and SOPs for QC laboratory activities.
- Liaises with QC Analytical Manager / QC Microbiology Manager / QC management and clients to design specific validation & stability protocols to suit individual project needs.
- Liaises with QA department on quality issues during creation of protocols.
- Assists with development/writing of SOPs or other quality documents and/or reports as needed.
- Authors change controls, deviations, CAPA, OOS investigations, review of material specifications, and other quality assurance related documentation as required to support the analytical laboratory activities.
- Maintains accurate files and records on USPL official server and maintains digital integrity.
- Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Comply with all job-related safety and other training requirements.
- Other duties as assigned
Requirements
Education & Qualification:
- Minimum master's degree in chemistry, Biology, or related field with 3-5+ years GMP related technical writing experience of protocols in pharma industry.
Certifications, Licenses, Credentials:
N/A
Skills & Ability
- Demonstrate strong command of English written and spoken language skills
- Possesses advanced MS Office software and have excellent typing skills
- Able to communicate corporate compliance issues to department heads
- Able to maintain professional and positive attitude
- Able to manage multiple tasks effectively & efficiently
- Possess high-level of ethics and integrity
- Must be able to keep information confidential
Physical Requirements (Lifting, etc.):
- Ability to navigate office, lab, and/or plant floor working environments.
- Standard office environment without unpleasant or hazardous conditions. Physical demands involved in office work such as the ability to talk, hear, use hands to handle and feel; work on a computer up to 7 hours a day; close vision required for computer usage.
- Must have the ability to wear applicable personal protective equipment utilized at this site, including safety glasses/goggles, hairnets, lab coats, gloves and safety shoes.
Work Environment (Office, Warehouse, temperature extremes, etc.):
- Ability to navigate office, lab, and/or plant floor working environments.
- Standard office environment without unpleasant or hazardous conditions. Physical demands involved in office work such as the ability to talk, hear, use hands to handle and feel; work on a computer up to 7 hours a day; close vision required for computer usage.
- Must have the ability to wear applicable personal protective equipment utilized at this site, including safety glasses/goggles, hairnets, lab coats and safety shoes.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.