Technical Writer III

ThermoFisher Scientific; Allentown (Lehigh County); On-site; USD 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific's Fisher Clinical Services in Allentown is seeking a Technical Writer and Investigator to support the Quality Management System by investigating deviations and complaints, writing clear technical concepts, and ensuring accurate documentation.

You will work with cross-functional teams to identify root causes, implement CAPAs, and help prepare SOPs, risk assessments, and related records, contributing to product quality and regulatory compliance.

Qualifications

• High school diploma required and 1 year GMP packaging experience.
• Strong written and verbal communication skills.
• Ability to read GMP and regulatory requirements.
• Experience with CAPA and root-cause analysis.

Responsibilities

• Investigates and responds to Quality Management System deviations and complaints.
• Writes technical concepts clearly to help clients analyze product impact.
• Completes CAPAs and effectiveness checks within the QMS.
• Develops SOPs and associated documentation.
• Interacts with internal stakeholders at all levels.

Skills

Technical writing

GMP compliance

Root cause analysis

SOP development

Microsoft Office

Education

High school diploma

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clients across the world. Whether planning, packaging, labeling, storing, or distributing important supplies, Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards.

Location/Division Specific Information

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time — a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

How will you make an impact?

As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.

What will you do?

Our company seeks a Technical Writer and Investigator, that investigates and responds to Quality Management System deviations and complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence. An ideal candidate has strong written and verbal communication skills and must be able to write technical concepts clearly and concisely with good punctuation and grammar to enable clients to effectively analyze product impact.

How will you get here?

Education

High school diploma required and one year of experience working in a Pharmaceutical Packaging/GMP environment.

Responsibilities

Conducts all activities in a safe and efficient manner.

Applies Good Manufacturing Principles in all areas of responsibility.

Demonstrates and promotes the company vision.

Performs the following duties through guidance from a more senior technical writer and investigator:

Composes technical concepts in a clear and concise manner to enable clients to analyze product impact and ensure prevention of reoccurrence.

Investigates and responds to Quality Management System deviations and complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence.

Conducts in-depth interviews to obtain and document accurate information.

Effectively completes CAPAs and effectiveness checks within the Quality Management System.

Establishes recommendations for changes to Standard Operating Procedures (SOPs) and associated documentation (i.e. protocol risk assessments).

Other duties may be assigned to meet business needs.

Knowledge, Skills, Abilities

Must be able to write technical concepts clearly and concisely with good punctuation and grammar to enable clients to effectively analyze product impact.

Experience in Microsoft Suite (i.e. Excel, Word, PowerPoint).

Ability to read and interpret GMP and other regulatory requirements.

Ability to work effectively and accurately in a fast-paced environment.

Must possess the ability to define problems, collect data, establish facts, and draw valid conclusions.

Must be able to utilize Root Cause Analysis techniques to identify and describe (write) the root cause and critical contributing factors to the event.

Must be able to work with subject matter experts to identify and document the Corrective and Preventative actions that will minimize the risk of a repeat occurrence of the event.

Must be able to effectively interact with internal contacts at all levels company-wide (IT, QA, Operations, Client Services, Supply Chain, etc.). Limited contact with external customers.

Must have the ability to effectively present information and respond to questions from senior management, peers, and clients.

Able to work independently and in a team environment.

Strong written and verbal communication skills.

Excellent prioritization skills.

Task and detail oriented.

Independent problem solver.

Ability to multi-task/manage multiple projects and strong ability to drive tasks/projects to closure by project deadline.

Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

Physical Requirements

Must be able to physically perform duties of position which include:

Exert up to 10lbs of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

Position may involve prolonged sitting but may involve walking or standing for brief periods of time.

May need stoop, reach or bend.

Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.