Job Description

Scientific Writer

This position supports the Quality Control (QC) department in developing clear, accurate, and well-organized technical documentation. The individual will work collaboratively across departments, primarily focusing on writing and leading investigations for QC-related Quality Events, while identifying and managing impacts to QC documentation from CAPAs, audits, and other process improvements. Additionally, the candidate will assist the QC writing team in producing essential technical documents, ensuring consistent formatting, and refining content for clarity and compliance with GxP standards. The ideal candidate should thrive in a collaborative, compliance-focused environment and possess the attention to detail necessary for performing thorough investigations and producing high-quality documentation in a (CDMO) setting.

What You'll Do:

• Work with SMEs and QC analysts to lead and support investigations of QC QEs including Laboratory Investigations, Deviations, Change Controls, conducting root cause analysis, and implementing CAPA measures to prevent recurrence.
• Lead projects independently to ensure that material is complete and accurate, translating complex technical information from SMEs into clear, well-organized content.
• Communicate with QC, QA, and SMEs across all departments to resolve issues, identify and close gaps.
• Track documentation throughout its lifecycle stages, from initial drafts through final approvals to ensure timely completion.
• Write and edit methods, SOPs, qualifications, validations, and other technical documentation using clear, plain language.
• Organize and streamline procedures and forms for improved usability and comprehension
• Ensure consistent formatting, structure, and style across various documents and documentation types
• Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.

What You'll Bring:

• Bachelor's degree or higher in a relevant scientific field (e.g., biology, biochemistry, molecular biology).
• 2-5 years experience in a GxP lab environment with experience in biochemical testing, laboratory procedures, and drafting and following written testing methods
• Understanding of deviation management processes and root cause analysis.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems
• Demonstrated expertise in technical writing, copy-editing, and document formatting
• Excellent communication skills, both written and verbal, with the ability to effectively communicate complex quality-related concepts to cross-functional teams.
• Skilled in translating scientific and technical information into clear, concise, and compliant documentation.
• Self-driven and proactive, with a strong ability to work independently while effectively collaborating with cross-functional teams in a fast-paced setting, adapting quickly to evolving project needs and timelines
• Exceptional organizational and time-management skills to efficiently prioritize tasks, balancing short-term demands with long-term project goals

Preferred:

• Strong knowledge of cGMP regulations, quality control, quality systems, and quality assurance principles.
• Experience with document control processes and systems, including SOPs, work instructions, methods, and forms.
• Familiarity with document management systems and knowledge of Quality Control documentation processes is a plus

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents

Competitive paid time off plan

Annual bonus for all full-time employees

401(K) company match

Fully-stocked kitchen with free food/drinks

12 weeks of paid parental leave - additional discount programs include childcare support & dependent care

Employee Assistance Program

Wellness benefits (financial planning services, mental health counseling, employer paid disability)

Onsite fitness facility

Professional & Personal development resources

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