Manufacturing Technical Procedure Writer

R&D Partners

Kansas

On-site

USD 60,000 - 140,000

Full time

14 days+

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Benefits offered by this job

Medical insurance – PPO, HMO & HSA

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Online timecard approval

Job summary

R&D Partners is seeking a Manufacturing Technical Procedure Writer to develop and maintain documentation supporting manufacturing operations. The role involves ensuring compliance with regulatory standards and collaborating with various teams to enhance operational efficiency. A bachelor's degree and technical writing experience in a regulated environment are required.

Qualifications

2+ years of technical writing experience in a regulated environment.
Familiarity with GMP and regulatory requirements preferred.

Responsibilities

Develop and update SOPs, batch records, and work instructions.
Ensure documentation complies with GMP, FDA, and EMA standards.
Collaborate with SMEs to gather technical information.

Skills

Technical Writing

Regulatory Compliance

Collaboration

Document Management

Education

Bachelor’s degree in Technical Writing

Bachelor’s degree in Pharmaceutical Sciences

Bachelor’s degree in Chemistry

Bachelor’s degree in Biology

Bachelor’s degree in Engineering

Job description

Manufacturing Technical Procedure Writer

Direct message the job poster from R&D Partners

R&D Partners is seeking to hire a Manufacturing Technical Procedure Writer in Norton, MA.

Your main responsibilities as a Manufacturing Technical Procedure Writer:

· Develop and Update Documentation: Write, edit, and maintain SOPs, batch records, work instructions, and other technical documents to support manufacturing operations, equipment use, and quality control processes.

· Ensure Regulatory Compliance: Ensure all documentation complies with GMP, FDA, EMA, and other relevant regulatory standards, as well as internal policies.

· Collaborate with Subject Matter Experts (SMEs): Work closely with manufacturing, quality assurance, validation, safety, and engineering teams to gather technical information and ensure accuracy and clarity in documentation.

· Streamline Processes: Translate complex technical processes into concise, user-friendly instructions to enhance operational efficiency and reduce errors.

· Document Control: Manage document lifecycle, including version control, reviews, approvals, and archiving, using electronic document management systems (EDMS).

What we are looking for in a Manufacturing Technical Procedure Writer:

· Bachelor’s degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field.

· 2+ years of technical writing experience in a pharmaceutical, biotechnology, or regulated manufacturing environment.

· Familiarity with GMP and regulatory requirements is highly preferred

· Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness

· Strong understanding of pharmaceutical manufacturing processes, equipment, and terminology.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including: