Quality Control Technical Writer

Position: Quality Control Technical Writer

Description:

The Quality Control Technical Writer is responsible for writing, reviewing and revising Quality Control documents, including but not limited to protocols, method validations, method qualifications, standard operating procedures (SOPs) and technical reports. The Quality Control Technical Writer can explain complex and technical information in a clear and concise manner. The Quality Control Technical Writer will work together with other departments as necessary to produce and revise cGMP documentation.  The Quality Control Technical Writer reports to the Director of Quality Control.

REQUIREMENTS:

Education and Experience:  

• Bachelor’s Degree in a scientific discipline, technical writing, or related scientific field
• Minimum 5 years of experience in Quality Control in a cGMP setting
• Minimum of 3 years of experience relevant to technical and document writing required
• Minimum of 2 years of laboratory bench work experience required. Previous experience in Quality Assurance may be considered for laboratory experience
• Specific experience should include: ELISA testing, ELISA assay development, analytical chemistry experience, laboratory record keeping, document writing and equipment maintenance
• Demonstrated record of working on multiple projects
• Knowledge of current US and International regulations as it pertains to documentation (e.g., USP, FDA, ISO, ICH) preferred
• Knowledge of pharmaceutical or biotechnology industry preferred

Skills/ Abilities:

• Excellent technical writing and document reviewing skills
• Time management
• Flexibility, has the ability to adapt to changes in assignments and/or priority levels
• Effectively communicate problems and suitable solutions as needed
• Excellent team, organizational, and problem-solving skills
• Strong communication and analytical skills, with strong technical judgement

Responsibilities:

• Create, write, and edit high quality text following company and department style requirements while following project guidelines, documentation standards, and templates
• Manage document(s) flow through approval (validations, protocols, reports, analytical methods, etc.)
• Support and complete documentation required for any revisions, changes or improvements per functional/departmental requirements (change control, procedure updates, document changes)
• Independently gathers information from subject matter experts or management to do the project planning and technical writing to ensure that Quality Control targets, timelines, and regulatory requirements are met
• Collects input for updates of documentation and does the updating in close cooperation with subject matter experts and/or department management

Work Hours:  

Position is full time. Monday through Friday – 8:00–4:30 (with 30 minute lunch)

Location: 

Elkridge, MD 

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.  

Please submit cv/resume and cover letter .  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.