Technical Writer

Integrated Resources Inc.; Marlborough (MA); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Récompense de référence

Job summary

Une entreprise dynamique recherche un rédacteur technique cGMP pour produire une documentation de qualité qui soutient les objectifs du projet. Le rôle implique la révision de procédures et la collaboration avec des experts techniques pour garantir la précision des documents. Idéal pour des candidats expérimentés qui peuvent gérer des projets multiples au sein d'un cadre réglementaire.

Qualifications

• 3+ ans d'expérience en rédaction technique dans un environnement cGMP.
• Expérience dans un cadre de fabrication sous cGMP et connaissance des exigences cGMP.
• Compétences exceptionnelles en communication et en organisation.

Responsibilities

• Rédiger, réviser et maintenir des SOP, PBR et documents de préparation de solutions.
• Collaborer avec des équipes internes pour générer et réviser des documents opérationnels.
• Gérer plusieurs projets indépendamment et efficacement.

Skills

Communication

Organizational Skills

Problem-Solving

Tools

MS Office Suite

Electronic Document Management Systems (EDMS)

Job description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

We are currently seeking a cGMP Technical Writer responsible for writing, reviewing, and driving production and quality documentation to approval.

• The Technical Document Writer will produce high-quality cGMP documentation contributing to the success of our project goals.
• Responsibilities include tracking the daily, weekly, and monthly forecasted documentation priorities to meet output quotas.

Key Responsibilities / Essential Functions

• Originate, revise, and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs), and Solution Preparation Records.
• Compile and draft procedural documentation using standard electronic publishing tools.
• Create and maintain templates for cGMP documents.
• Collaborate with internal teams to generate and review equipment, processing, set-up, and operational documents within timelines.
• Interview subject matter experts to accurately capture content details.
• Demonstrate effective written and verbal communication skills.
• Monitor production document flow and adjust workload and resources efficiently.
• Work with cross-functional teams on process improvement initiatives to enhance cGMP documentation quality.
• Manage multiple projects independently and effectively.
• Maintain a safe work environment for self and staff.

Qualifications

• 3+ years of technical writing experience in a cGMP pharmaceutical environment.
• Experience in manufacturing under cGMP guidelines and strong knowledge of cGMP requirements.
• Prior experience in biotech/pharmaceutical companies.
• Exceptional communication, organizational, research, investigative, and problem-solving skills.
• Ability to communicate complex ideas clearly and concisely.
• Proficiency in MS Office Suite and Electronic Document Management Systems (EDMS).

Additional Information

Feel free to share this opportunity with colleagues. We offer a referral bonus.

Thank you.

Kind Regards,

Clinical Recruiter

Integrated Resources, Inc.

DIRECT #: (650)-399-0891

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