ZipRecruiter is hiring: QA Technical Writer in Langhorne

Quality Assurance Technical Writer

Purpose:

Primary responsibilities include performing GMP investigations, developing and create CAPAs, and providing guidance to change control owners regarding change control content and risk assessments. This role will investigate deviations and customer-related complaints associated with the Quality Assurance department and will also support the GMP deviation process throughout the site. Investigations will require review of all related documents and data, and interviewing relevant personnel to identify the root cause and corrective actions required. Responsibilities will also include revising or correcting any related documents pertinent to the conclusion of the investigation (i.e. SOP’s) while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA (where applicable).

Key Duties & Responsibilities

• Prepare Quality Event Records (including deviations, planned deviations and product complaint investigations)
• Prepare and Review Out of Specification (OOS) investigations for internal and external analyses.
• Prepare and Review Risk Assessments, CAPAs, Change Control documents and Standard Operating Procedures (SOPs)
• Prepare and review Change Control records
• Handles and completes special projects as required
• Other duties as required or delegated
• Continuous working knowledge of applicable cGMP guidelines
• Continuous working knowledge of applicable DEA regulations

Education

Education Requirement:

B.S. or higher degree from an accredited college/university in a scientific discipline

Technical Competencies

• Practical working knowledge of Sterile Pharmaceutical Manufacturing Operations
• Excellent English writing, spelling, punctuation, and grammar skills
• Ability to interpret complex data and draw valid conclusions
• Proficient in the use of spreadsheets, databases, presentation, and word processing software. Basic Microsoft Office proficiency is expected.
• Strong interpersonal skills and the ability to effectively work and communicate with cross-functional teams
• The position must follow all data integrity and good documentation practice requirements.
• Strong organizational and multi-tasking abilities
• Self-motivated, work well independently and as a team player and re-prioritize workload as required