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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

Gold Seal JCAHO Certified for Health Care Staffing

"INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)