<p>Job Title: Technical Writer</p> <p>Job Description</p> <p>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.</p> <p>Responsibilities</p> <ul> <li>Investigate and resolve all deviations. </li><li>Close and resolve all document reviews. </li><li>Revise, edit, and create SOPs and work instructions. </li><li>Create quality documents in adherence to internal and regulatory standards. </li><li>Participate in cross-functional work with Tech Operations, Quality, and Manufacturing teams. </li><li>Ensure compliance in documentation procedures. </li><li>Maintain quality systems. </li><li>Assist in training company employees on documentation procedures. </li></ul> <p>Essential Skills</p> <ul> <li>Quality assurance </li><li>CAPA (Corrective and Preventive Actions) </li><li>Deviation management </li><li>Work instructions development </li><li>SOP creation and revision </li><li>Document review </li><li>Documentation quality assurance </li><li>Batch record review </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field. </li><li>Minimum 5-10 years of experience in a GMP-regulated pharmaceutical or biotechnology environment. </li><li>At least 3-5 years of experience in document control. </li><li>Strong knowledge of cGMP, ICH Q10, FDA, EMA, and other global regulatory requirements. </li><li>Proficiency in quality systems software such as TrackWise. </li></ul> <p>Work Environment</p> <p>The position is 100% onsite, Monday through Friday, in Billerica, MA, where you will be part of the tech operations team supporting quality initiatives.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $80.00 - $95.00/hr.</p> <p>Eligibility requirements apply to some benefits and may depend on your job</p> <p>classification and length of employment. Benefits are subject to change and may be</p> <p>subject to specific elections, plan, or program terms. If eligible, the benefits</p> <p>available for this temporary role may include the following:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in North Billerica,MA.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Jun 27, 2025.</p> <p>About Actalent</p> <p>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.</p> <p>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.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>