Manufacturing Pharmaceutical Technical Writer/Documentation Specialist

Company Overview:

A&Z Pharmaceutical Inc. is a pioneering leader in the development, manufacturing, and marketing of high-quality pharmaceutical products and nutritional supplements. With over 30 years of industry experience, the company operates globally with dedicated research laboratories and manufacturing facilities committed to advancing health and wellness worldwide.

Job Overview:

We are seeking a dynamic and detail-oriented Technical Writer in the pharmaceutical industry. In this role, you will be responsible for creating, editing, and maintaining high-quality documentation, including Standard Operating Procedures (SOPs), regulatory submissions, batch records, and technical reports. The Technical Writer bridges the gap between complex scientific data and regulatory requirements, ensuring compliance with cGMP (current Good Manufacturing Practices) and FDA guidelines.

Key Responsibilities:

• Standard Operating Procedure (SOP) Writing:
• Draft, edit, and maintain SOPs, validation protocols, and master batch records.
• Ensure all documents adhere to FDA, and other regulatory standards, contributing to submissions and audits.
• Regularly review and update SOPs in line with technological or process changes.

Execution of Equipment Qualification (IOPQ):

• Assist in the execution of IOPQ protocols for equipment and processes.
• Collaborate with senior team members to ensure protocols are followed accurately and completely.
• Document results and any deviations, reporting to the Technical Operations Manager.

Technical Document Management:

• Organize, store, and manage technical documents in a systematic manner.
• Ensure easy access to documents for all relevant departments while maintaining security and confidentiality.
• Regularly review and update documents to ensure they are current and compliant.
• Identify gaps in current processes and update documentation to reflect improvements or correct deviations.

Equipment Recordkeeping and Maintenance Scheduling:

• Maintain an up-to-date list of all equipment, including their specifications, locations, and status.
• Collaborate with QA team to schedule and track regular maintenance, ensuring minimal operational disruption.
• Collaborate with the maintenance team to preempt potential equipment issues.

Change Control Management:

• Collaborate with QA team to understand the implications and requirements of potential changes.
• Track and monitor the status of change controls, ensuring relevant stakeholders are kept informed.
• Assist in drafting initial change control requests, ensuring all relevant details are accurately captured.

Requirements and Qualifications

• Bachelor’s degree in scientific, medical, or technical field (e.g., Chemistry, Biology, Pharmacy) or English/Communications with relevant experience.
• 1–3 years of technical writing experience, ideally in pharmaceutical, nutraceutical, biotechnology, or medical device environments.
• Strong understanding of cGMP (current Good Manufacturing Practices).
• Expertise in MS Office Suite (Word, Excel) and experience with document management systems.
• Meticulous approach to reviewing and editing to prevent errors in manufacturing or reporting.

Job Type: Full-time

Pay: $50,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Draft, edit SOPs, validate protocols, master batch records.: 1 year (Required)

Location:

• Hauppauge, NY 11788 (Required)

Shift availability:

• Day Shift (Required)

Work Location: In person

Salary : $50,000 - $65,000