R&D Design Control Specialist

BioGX is a global molecular diagnostics company focused on the health and safety of communities all over the world. We design, develop and manufacture products and devices for Clinical, Water Quality, Food Safety and Pharma Quality. We are headquartered in Birmingham, AL.

 

Purpose of Position/Essential Duties (other duties may be assigned):

  • Explain technical ideas in simple language
  • Own end-to-end documentation creation process
  • Work closely with internal teams to deeply understand product and documentation requirements
  • Write, edit, and review design control and risk management documents that meet Quality Management System standards
  • Write, rewrite and/or edit technical documents such as technical procedure manuals, user manuals, programming manuals, service manuals, operational specifications, and related technical publications to communicate clearly and effectively technical specifications and instructions to a wide range of audiences.
  • Create manufacturing documentation for a variety of products and processes, including work Instructions, SOPs, flow charts and other work aids.
  • Meet and collaborate with scientists, quality, product management, and manufacturing to define and establish operational procedures and manuals for operational activities and tasks.
  • Write clearly and concisely to meet the needs of the target audience.
  • Prepare process flows, specifications, mockups.
  • Actively participate as a member of cross-functional new product development teams to ensure compliance with design controls per ISO 13485 and other regulatory requirements.
  • Work with minimal supervision and manage time effectively.

 

Education/ Qualifications:

  • Bachelor’s Degree in a science related field and 5+ years of technical writing experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.
  • Experience with ISO 9001, ISO 13485, and/or GMP environments.
  • Strong understanding of Design Control and Change Control.
  • Experience in writing scientific papers is preferred.
  • Excellent written and verbal communication skills.
  • Proficiency in MS Office.
  • Experience working in the regulated medical device industry

 

Knowledge, Skills, Abilities:

  • Strong attention to detail and high regards for quality.
  • Able to write in explanatory and procedural styles for multiple end users.
  • Skilled at prioritization and multitasking in a self-driven, performance/results oriented, fast paced matrixed environment.
  • Must be highly collaborative: enjoys working in a diverse team and contributes to a positive work environment.
  • Understanding of FDA and international regulations, requirements, and guidances related to submissions, reporting, and document preparation
  • Ability to quickly translate complex processes \into easily understood writing, diagrams, and technical illustrations

 

Language Skills:

Must be proficient in writing, and communicating in the English language including presenting of data and results.  Computer literate with a working knowledge of Microsoft Word and Excel.

 

Mathematical Skills:

Must be consistent with level education.

 

Reasoning Ability:

Good problem solving, judgment and decision making skills are required.  High degree of organizing skill, planning skill, prioritization skill.  Multitasking ability.

 

Certifications, Licenses, Registrations:

None required

 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance.  Work entails occasional lifting and/or moving up to 25 pounds.  Work occasionally requires travel between buildings.  This is typically completed by foot or by car.

 

The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.

 

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration.  The noise level in the work environment is usually moderate.

Job Category: Research and Development
Job Type: Full Time
Job Location: Birmingham, AL