QS Technical Writer - Nice Pak
Orangeburg, NY
About the Job
Description
Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!
POSITION PURPOSE
The Quality Systems Technical Writer is responsible for supporting the Quality Systems team as well as the broad organization by producing clear and concise documentation as well as creating innovative ideas for content while working both independently and collaboratively as part of the team. The Quality Systems Technical writer plays a crucial role in ensuring compliance with regulatory requirements and facilitating effective communication within our organization and with external stakeholders. Additionally, the role ensures that all documentations adheres to established guidelines and best practices and supports the conversion of complex information into user-friendly documents.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
+ Reviews local Quality Management System (QMS) documents to ensure clear & reader friendly language.
+ Develop/Edit Standard Operating Procedures and Work Instructions related to processes used in a Pharmaceutical GMP environment, adhering to standards, templates, and best practices.
+ Collaborates cross-functionally with other departments &maintains stakeholder relationshipsProvides specialist knowledge on the writing process to ease understanding, choice of document type, structure, style & language usage of the operational documents.
+ Coaches document owners in the knowledge of good communication & standards in operational documents.
+ Review and/or copyedit content developed by other members of the team Determine the clearest and most logical way to present information for greatest reader comprehension.
+ Supports document owners in the writing process with language usage, document revision process, standardization, change control process & related tools
+ Generate innovative ideas for content and workflow solutions
+ Attend and/or Facilitate Subject Matter Expert meetings to define/refine document content and gain alignment between stakeholders.
+ Participate in Process Team meetings to support project planning related to Technical Writing support
+ Complete special projects/tasks as assigned
PERFORMANCE MEASUREMENTS
+ On time completion of clear and concise new documents or revisions to existing documentation
+ On time completion of special projects/tasks assigned
EDUCATION/CERTIFICATION
+ Associate's degree in life science, pharmaceutical sciences, chemistry, or a related field or equivalent combination of education & experience required. Bachelor's degree preferred
REQUIRED KNOWLEDGE
+ Advanced technical writing skills and the ability to communicate effectively with peers, department management, and cross-functional coworkers
+ Familiarity with compliance requirements within cGMP with an emphasis on procedures, process validations, and reporting requirements preferred
+ Ability to read, write & understand complicated product documentation & standard operating procedures with attention to high-level concepts
+ Knowledgeable in core work processes & GMP concepts, knowledge of process improvement methodologies such as LEAN a plus
+ Understanding of analytical techniques and methodologies
+ Understanding and experience with problem solving techniques (root cause analysis) is preferred
REQUIRED EXPERIENCE
+ Five (5) years of experience in technical writing, preferably in a pharmaceutical or other life sciences environment.
+ Advanced word processing using Microsoft Word and other Microsoft Office products.
+ Experience working in an Electronic Document Management System (EDMS)
SKILLS/ABILITIES
+ Superior written and verbal communications skills
+ Strong fluency in the English language and grammatical application thereof
+ Advanced MS Word skills, including using styles and formatting tables, demonstrated competency with MS Excel, PowerPoint, and Outlook
+ Able to multi-task and quickly adjust to changing priorities without sacrificing quality or timely task completion
+ Highly organized, accountable, and able to work in an independent and self-directed work environment
WORKING CONDITIONS
+ No hazardous or significantly unpleasant conditions
SALARY RANGE
+ $70,000 - $80,000 annually
BENEFITS
PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:
+ Medical, behavioral & prescription drug coverage
+ Health Savings Account (HSA)
+ Dental
+ Vision
+ 401(k) savings plan with company match and profit sharing
+ Basic and supplemental Life and AD&D insurance
+ Flexible Spending Accounts (FSAs)
+ Short & long-term disability
+ Employee Assistance Program (EAP)
+ Health Advocacy Program
PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
#LI-PDI
#LI-ONSITE
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!
POSITION PURPOSE
The Quality Systems Technical Writer is responsible for supporting the Quality Systems team as well as the broad organization by producing clear and concise documentation as well as creating innovative ideas for content while working both independently and collaboratively as part of the team. The Quality Systems Technical writer plays a crucial role in ensuring compliance with regulatory requirements and facilitating effective communication within our organization and with external stakeholders. Additionally, the role ensures that all documentations adheres to established guidelines and best practices and supports the conversion of complex information into user-friendly documents.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
+ Reviews local Quality Management System (QMS) documents to ensure clear & reader friendly language.
+ Develop/Edit Standard Operating Procedures and Work Instructions related to processes used in a Pharmaceutical GMP environment, adhering to standards, templates, and best practices.
+ Collaborates cross-functionally with other departments &maintains stakeholder relationshipsProvides specialist knowledge on the writing process to ease understanding, choice of document type, structure, style & language usage of the operational documents.
+ Coaches document owners in the knowledge of good communication & standards in operational documents.
+ Review and/or copyedit content developed by other members of the team Determine the clearest and most logical way to present information for greatest reader comprehension.
+ Supports document owners in the writing process with language usage, document revision process, standardization, change control process & related tools
+ Generate innovative ideas for content and workflow solutions
+ Attend and/or Facilitate Subject Matter Expert meetings to define/refine document content and gain alignment between stakeholders.
+ Participate in Process Team meetings to support project planning related to Technical Writing support
+ Complete special projects/tasks as assigned
PERFORMANCE MEASUREMENTS
+ On time completion of clear and concise new documents or revisions to existing documentation
+ On time completion of special projects/tasks assigned
EDUCATION/CERTIFICATION
+ Associate's degree in life science, pharmaceutical sciences, chemistry, or a related field or equivalent combination of education & experience required. Bachelor's degree preferred
REQUIRED KNOWLEDGE
+ Advanced technical writing skills and the ability to communicate effectively with peers, department management, and cross-functional coworkers
+ Familiarity with compliance requirements within cGMP with an emphasis on procedures, process validations, and reporting requirements preferred
+ Ability to read, write & understand complicated product documentation & standard operating procedures with attention to high-level concepts
+ Knowledgeable in core work processes & GMP concepts, knowledge of process improvement methodologies such as LEAN a plus
+ Understanding of analytical techniques and methodologies
+ Understanding and experience with problem solving techniques (root cause analysis) is preferred
REQUIRED EXPERIENCE
+ Five (5) years of experience in technical writing, preferably in a pharmaceutical or other life sciences environment.
+ Advanced word processing using Microsoft Word and other Microsoft Office products.
+ Experience working in an Electronic Document Management System (EDMS)
SKILLS/ABILITIES
+ Superior written and verbal communications skills
+ Strong fluency in the English language and grammatical application thereof
+ Advanced MS Word skills, including using styles and formatting tables, demonstrated competency with MS Excel, PowerPoint, and Outlook
+ Able to multi-task and quickly adjust to changing priorities without sacrificing quality or timely task completion
+ Highly organized, accountable, and able to work in an independent and self-directed work environment
WORKING CONDITIONS
+ No hazardous or significantly unpleasant conditions
SALARY RANGE
+ $70,000 - $80,000 annually
BENEFITS
PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:
+ Medical, behavioral & prescription drug coverage
+ Health Savings Account (HSA)
+ Dental
+ Vision
+ 401(k) savings plan with company match and profit sharing
+ Basic and supplemental Life and AD&D insurance
+ Flexible Spending Accounts (FSAs)
+ Short & long-term disability
+ Employee Assistance Program (EAP)
+ Health Advocacy Program
PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
#LI-PDI
#LI-ONSITE
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Source : Nice Pak
