Quality Specialist/Technical Writer

Masis Professional Group

Bethlehem (Northampton County)

On-site

USD 75,000 - 85,000

Full time

14 days+

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Job summary

A leading pharmaceutical manufacturer located in Bethlehem is seeking a Quality Specialist/Technical Writer. This role focuses on ensuring compliance with regulatory requirements and supporting the production of inhalation anesthetics. Candidates should have a Bachelor’s degree, over 5 years of industry experience, and expertise in validation processes. The position offers a competitive salary ranging from $75,000 to $85,000 annually and is a contract role.

Qualifications

5+ years of combined experience in compliance and project management.
Deep understanding of cGMPs and regulatory standards.
Exceptional verbal and written communication skills.

Responsibilities

Provide documentation and compliance support for regulatory requirements.
Partner with departments to address GMP requirements.
Manage multiple priorities and lead team members.
Oversee validation and compliance systems.

Skills

Validation and qualification oversight

Managing customer complaints investigations

Document control expertise

Drafting qualification documents

Problem-solving skills

Proficiency in Microsoft Office

Education

Bachelor’s degree in a scientific field

5+ years in pharmaceutical industry

Job description

Overview

Join a leading Pharmaceutical Manufacturing site in a long-term contract role as a Quality Specialist/Technical Writer. In this position, you’ll play a vital role in driving compliance, elevating operational standards, and supporting the production of Inhalation anesthetics that impact patients worldwide.

Compensation

Base pay range: $75,000.00/yr - $85,000.00/yr

This range is provided by Masis Professional Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Responsibilities

Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products.
Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control.
Manage multiple priorities while providing leadership, guidance, and feedback to team members.
Drive packaging OEE (Overall Equipment Effectiveness) initiatives.
Oversee validation, qualifications, customer complaints, investigations, and systems compliance.
Maintain oversight of the PAS-X system and ensure 24/7 audit readiness.
Support regulatory audits with thorough preparation and follow-through.
Lead document control activities to ensure accuracy, consistency, and compliance.

Critical Skills for Success

Hands-on oversight of validation and qualification processes.
Expertise in managing customer complaints and related investigations.
Strong background in document control and procedure updates.
Ability to draft and execute qualification documents and summary reports.

Education & Experience

Bachelor’s degree or higher in a scientific, quality assurance, or technical field.
5+ years of combined experience in the pharmaceutical or related regulated industry, including compliance and project management.
Deep understanding of cGMPs, regulatory standards, and industry best practices.
Proven ability to conduct investigations, interpret regulations, and make sound quality decisions.
Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels.
Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems.
Strong problem-solving skills with the ability to lead projects and deliver timely results.

Why This Role Matters

This is more than just a writing role—it’s an opportunity to influence quality and compliance at a site manufacturing APIs that directly support patient safety worldwide. If you thrive on precision, teamwork, and making a measurable impact, this contract role offers both stability and purpose.

Seniority level