Data Writer

Description:

Empower Pharmacy is seeking a Quality Control Technical Data Writer - Microbiology to join their team in East Windsor, NJ. This pivotal role focuses on transforming complex analytical data and laboratory findings into accurate, compliant, and well-structured documentation that ensures regulatory alignment and data integrity. The role serves as a bridge between science and communication, contributing to Empower Pharmacy’s mission to expand access to safe, affordable, and innovative medications through precise and transparent recordkeeping.

The Quality Control Technical Data Writer will be responsible for creating, reviewing, and editing technical documentation such as analytical test methods, Certificates of Analysis (COA), Standard Operating Procedures (SOPs), and deviation reports. The position requires strict adherence to FDA, USP, and cGMP guidelines while maintaining consistency and accuracy across all records and reports. The ideal candidate will work closely with Quality Control (QC) analysts, laboratory personnel, and Quality Assurance (QA) teams to ensure documentation meets regulatory and operational standards.

The role demands a meticulous attention to detail, strong technical writing skills, and a comprehensive understanding of regulatory frameworks such as FDA, cGMP, USP 795, 797, 800, and ICH guidelines. The individual will also be responsible for managing document control systems, ensuring version accuracy, and supporting both internal and external audits through well-prepared, compliant documentation.

Key Responsibilities:

• Create, review, and edit QC documentation including analytical methods, SOPs, COAs, and deviation reports.

• Translate raw laboratory data and technical reports into regulatory-compliant, easily interpretable documentation.

• Collaborate with QC, QA, and regulatory teams to resolve documentation discrepancies and maintain data integrity.

• Ensure compliance with FDA, cGMP, CFR, and ICH guidelines while promoting continuous improvement in documentation quality.

• Maintain centralized systems for document control and ensure readiness for audits and inspections.

• Support communication and knowledge-sharing across cross-functional departments.

Knowledge and Skills:

• Strong command of technical writing, document management systems, and data verification.

• Knowledge of FDA, USP, and cGMP standards.

• Proficiency in translating complex scientific data into clear and concise documentation.

• Excellent communication, collaboration, and problem-solving skills.

• Ability to manage multiple projects and maintain high standards under regulatory scrutiny.

Key Competencies:

• Customer Focus: Builds strong, customer-centric relationships.

• Optimizes Work Processes: Drives efficiency and continuous improvement.

• Collaboration: Works effectively across teams to achieve shared objectives.

• Resourcefulness: Allocates and utilizes resources efficiently.

• Manages Complexity: Simplifies complex and contradictory information.

• Accountability: Ensures commitments and deliverables are consistently met.

• Adaptability: Adjusts approaches to meet changing demands.

• Effective Communication: Delivers clear and accurate messages tailored to diverse audiences.

Core Values:

• People: Empowering and supporting the company’s team, clients, and community.

• Quality: Commitment to excellence in every product and process.

• Service: Delivering value and care through every interaction.

• Innovation: Embracing new methodologies and technology to advance pharmaceutical care.

Experience and Qualifications:

• Minimum of 3 years in a QC, QA, or technical documentation role within pharmaceuticals or life sciences.

• Bachelor’s degree in Technical Writing, English, Communications, Chemistry, Biology, Pharmaceutical Sciences, or a related field.

• Preferred certifications: Certified Quality Auditor (CQA), ASQ Technical Writing, or Lean Six Sigma (LSS).

Benefits:

• Comprehensive health coverage (medical, dental, and vision)

• Paid time off and 401(k) matching

• Wellness perks including IV therapy and compounded medications

• Additional employee well-being benefits