(Contract) Quality Technical Writer

Kymanox • Morrisville, NC

7d • Onsite

About The Position

Kymanox is seeking a Technical Writer – General QMS (Contract) to perform technical writing and client support on a site readiness project. This role involves authoring a range of engineering, compliance, and commercialization Standard Operating Procedures (SOPs). The ideal candidate will be motivated by making a difference, having an impact, and working with subject matter experts to learn and grow, ultimately contributing to better patient outcomes.

Requirements

• A minimum of 3 to 5 years of experience in development and/or manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
• Excellent written and oral English communication skills.
• Understanding of own limitations.
• Ability to solicit and utilize subject matter expert input.
• Fast learner.
• Pleasant and positive communication style.
• Strong customer-service aptitude.
• Ability to motivate self, team members, and direct reports.
• High energy level.
• Excellent problem-solving skills.
• Seasoned soft skills (i.e., high EQ).
• Team player.

Nice To Haves

• Senior level 8-15 years of experience in technical writing within the Pharma, Medical Device, or BioTech industries is desired.
• Bachelor’s degree in any Engineering discipline (prefer Biomedical, Mechanical, or Chemical engineering) or other STEM discipline (Biology, Chemistry, other) from an accredited institution or equivalent.
• Resourceful.
• Extremely detail oriented.
• Ability to work effectively with remote team members.
• Highly organized.
• Self-directing, self-pacing.

Responsibilities

• Authoring Standard Operating Procedures (SOPs) for engineering, compliance, and commercialization.
• Technical writing may include focus areas such as: Manufacturing equipment and processes, Quality Control Laboratory instruments and methods, Utility systems, Facilities and maintenance equipment, Logistics and warehousing processes, Quality Assurance processes, Environment, Health, and Safety processes, Warehouse and Supply Chain, Information Technology, and Training content.

Benefits

• Hourly rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.
• Travel may be necessary to support client work.

What This Job Offers

• Career Level: Mid Level
• Education Level: Associate degree