QA Technical Writer

Planet Pharma; Memphis (TN); On-site; USD 41,000 - 44,000; Full time

Job summary

Planet Pharma in Memphis, TN is seeking a Compliance Specialist to create, manage, and maintain technical documentation for our cell and gene therapy manufacturing site. You will write, edit, and review quality system documents to support deviations, CAPAs, and change controls, ensuring accuracy and regulatory compliance.

The ideal candidate has 2–6 years in biotech or pharmaceutical technical writing, strong writing and editing skills, and proficiency with MS Office and document management

Qualifications

• Associate’s degree or higher in Life Sciences, Biotechnology, Biochemistry, or related field.
• Minimum of 2–6 years of technical writing experience in biotech or pharmaceutical industry, preferably in cell and gene therapy.
• Exceptional writing, editing, and proofreading skills with attention to detail.
• Ability to interpret and present complex scientific data in a clear and concise manner.
• Proficient in Microsoft Office Suite and document management systems.
• Strong organizational and project management skills.
• Excellent communication and interpersonal skills.

Responsibilities

• Generate and leading the facilitation in the completion of quality system documents for the manufacturing site (Deviations, CAPAs, Change Controls, etc.)
• Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines
• Complete routine and some non-routine documentation assignments within prescribed timeline under general supervision
• Work closely with stakeholders to gather information and ensure accuracy and completeness of documentation
• Facilitate document reviews and approvals, incorporating feedback from cross-functional teams and clients
• Collaborate in writing and editing technical documents including standard operating procedures (SOPs), batch records, technical reports, etc
• Communicate results and/or concerns verbally and in writing
• Develop and maintain relationships with internal stakeholders as well as begin building relationships with clients
• Provides solutions of moderate to complex scope to continuously improve documentation processes and templates to enhance clarity, efficiency, and compliance
• Leads in performing trainings for internal team and functional departments as applicable
• Perform other duties as assigned

Skills

Technical writing

Clear communication

Editing

Attention to detail

Project management

Education

Associate degree or higher in Life Sciences or related field

Tools

Microsoft Office Suite

Job description

POSITION SUMMARY

Reporting to the Manager Compliance, the Compliance Specialist is responsible for creating, managing, and maintaining technical documentation for our cell and gene therapy manufacturing site. This includes writing, editing, and reviewing documents such as quality systems (deviations, change controls and capas). The ideal candidate will be a critical thinker with experience in biotechnology or pharmaceuticals, excellent writing skills, and ready to apply specialized skills in technical writing, compliance, data analysis…etc..in a regulated environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Generate and leading the facilitation in the completion of quality system documents for the manufacturing site (Deviations, CAPAs, Change Controls, etc)
• Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines
• Complete routine and some non-routine documentation assignments within prescribed timeline under general supervision
• Work closely with stakeholders to gather information and ensure accuracy and completeness of documentation
• Facilitate document reviews and approvals, incorporating feedback from cross-functional teams and clients
• Collaborate in writing and editing technical documents including standard operating procedures (SOPs), batch records, technical reports, etc
• Communicate results and/or concerns verbally and in writing
• Develop and maintain relationships with internal stakeholders as well as begin building relationships with clients
• Provides solutions of moderate to complex scope to continuously improve documentation processes and templates to enhance clarity, efficiency, and compliance
• Leads in performing trainings for internal team and functional departments as applicable
• Perform other duties as assigned

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

• Associate’s degree or higher in Life Sciences, Biotechnology, Biochemistry, or related field preferred
• Minimum of 2-6 years of technical writing experience in the biotechnology or pharmaceutical industry, preferably in cell and gene therapy
• Exceptional writing, editing, and proofreading skills with attention to detail
• Ability to interpret and present complex scientific data in a clear and concise manner
• Proficient in Microsoft Office Suite and document management systems
• Strong organizational and project management skills
• Excellent communication and interpersonal skills

Additional Requisition Requirements

• Must be able to sit/walk for long periods of time.
• Must be able to lift, push, pull to 10 lbs. routinely; 20 lbs. occasionally.
• Must be able to work standing, bending, and reaching overhead occasionally.
• Must be able to move sufficiently between multiple office and facility locations.
• Must have visual acuity to use a keyboard, computer monitor, operate equipment

The max pay rate is $30-32/hr for this position