Technical Writer Position Available In Middlesex, Massachusetts

Technical Writer Actalent Services – 3.5 Billerica, MA Job Details Full-time $40 – $50 an hour 13 hours ago Qualifications Biotechnology CGMP Management GMP Master’s degree 8 years Bachelor’s degree ICH Q10 Pharmacy Root cause analysis Senior level FDA regulations Full Job Description We are seeking a Technical Writer with expertise in quality documentation, investigation reporting, and compliance within the biotech and pharmaceutical sectors. This role requires strong collaboration skills, analytical thinking, and the ability to translate complex processes into clear, actionable documentation aligned with regulatory standards and internal quality systems.

Key Responsibilities:

Develop, edit, and revise Policies, SOPs, Work Instructions, and other quality documents, ensuring clarity, consistency, and compliance. Collaborate cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to collect data and ensure accurate, complete, and timely documentation. Drive the closure of investigations and deviations in accordance with internal procedures and regulatory expectations. Facilitate and lead cross-functional team meetings focused on deviation management and investigation progress. Author and review investigation reports, CAPAs, and trend analyses to ensure clarity, scientific soundness, and regulatory readiness. Support training initiatives by developing documentation that facilitates SOP implementation and operational workflows.

Additional Skills & Qualifications:

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field. Minimum 8-10 years of experience in a GMP-regulated pharmaceutical or biotechnology environment, with at least 5-7 years focused on deviation management and investigations. Strong knowledge of c

GMP, ICH

Q10, FDA, EMA, and other global regulatory requirements. Demonstrated expertise in root cause analysis and CAPA development. Proficiency in quality systems software (e.g., TrackWise, Veeva Vault QM).

Job Type:

Full-time Pay:

$40.00 – $50.00 per hour Expected hours: 40 per week

Schedule:

8 hour shift Day shift

Work Location:

In person