Technical Writer Position Available In Middlesex, Massachusetts

Job Title:

Technical Writer Job Description The role of the Technical Writer involves supporting the team with specific quality events and revising, editing, and creating Standard Operating Procedures (SOPs) and work instructions. The position requires creating quality documents to ensure they adhere to all internal and regulatory standards, participating in cross-functional collaboration with Tech Operations, Quality, and Manufacturing teams, and ensuring compliance in documentation procedures. The Technical Writer will also help maintain all quality systems and assist with training employees on documentation procedures to ensure all SOPs meet regulatory compliance. Responsibilities Investigate and resolve all deviations. Close and resolve all document reviews. Revise, edit, and create SOPs and work instructions. Create quality documents in adherence to internal and regulatory standards. Participate in cross-functional work with Tech Operations, Quality, and Manufacturing teams. Ensure compliance in documentation procedures. Maintain quality systems. Assist in training company employees on documentation procedures. Essential Skills Quality assurance CAPA (Corrective and Preventive Actions) Deviation management Work instructions development SOP creation and revision Document review Documentation quality assurance Batch record review Additional Skills & Qualifications Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field. Minimum 5-10 years of experience in a GMP-regulated pharmaceutical or biotechnology environment. At least 3-5 years of experience in document control. Strong knowledge of c

GMP, ICH

Q10, FDA, EMA, and other global regulatory requirements. Proficiency in quality systems software such as TrackWise. Work Environment The position is 100% onsite, Monday through Friday, in Billerica, MA, where you will be part of the tech operations team supporting quality initiatives.