Job Information
Actalent Technical Writer in Cranbury, New Jersey
Fantastic Technical Writer opportunity with a growing Pharmaceutical company!
Job Summary:
The candidate will be responsible for developing, reviewing, and maintaining technical documents related to ARD/QC operations, ensuring compliance with regulatory guidelines (FDA, ICH, USP, EP, cGMP) and company in-house standards. This role requires strong collaboration with QC analysts, scientists, and Quality Assurance teams to produce clear, accurate, and well-structured documentation.
Key Responsibilities:
- Document Development & Maintenance
Write, edit, and maintain Standard Operating Procedures (SOPs), test methods, specifications, work instructions, and protocols related to Quality Control and Analytical Development.
Develop and update analytical test reports/COA’s, validation protocols (IQ/OQ/PQ), and stability study reports.
Prepare method validation protocol/reports, method transfer protocol/reports, technical documents, including change controls, deviations, CAPAs, and OOS (Out of Specification) and laboratory investigations.
Ensure consistency, clarity, and compliance in all documentation.
Maintain up-to-date copies of all cGMP documents in the laboratory and relevant databases.
- Compliance & Regulatory Support
Ensure all QC documentation aligns with FDA, ICH, USP, EP, cGMP, and other regulatory guidelines.
Assist in preparing documentation for regulatory submissions and audits (internal and external).
Maintain accurate version control and document tracking within electronic document management systems (ACE)
- Collaboration & Communication
Work closely with QC analysts, Outside Contract Testing Laboratories, customer, equipment manufactures and Quality Assurance to gather technical information.
Assist in reviewing and updating documents based on feedback from Quality Assurance (QA) and Customers.
Provide guidance to QC personnel on documentation best practices and compliance requirements.
- Training & Continuous Improvement
Develop training materials for QC team members on updated SOPs, specifications and test methods.
Support quality improvement initiatives by identifying gaps in documentation and recommending improvements.
Stay up to date with industry best practices, regulatory changes, and advancements in pharmaceutical quality control.
Qualifications & Requirements:
Education: Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, Biotechnology, or a related field.
Experience: 2-5 years of experience in technical writing within the pharmaceutical, biotech industry, preferably in Quality Control/Analytical Development.
Technical Skills:
Strong understanding of analytical techniques (HPLC, GC, UV-Vis, FT-IR, Malvern PSD, Water by KF and Dissolution, etc.) and laboratory procedures.
Familiarity with regulatory guidelines such as FDA, ICH, USP, EP, cGMP, and GLP.
Pay and Benefits
The pay range for this position is $80000.00 - $100000.00/yr.
Medical, dental, vision, 401k, PTO and holiday pay
Workplace Type
This is a fully onsite position in Cranbury,NJ.
Application Deadline
This position is anticipated to close on May 6, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.