Quality - Technical Writer

Immediate need for a talented Quality - Technical writer. This is a 06+ months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 24-24556

Pay Range: $50 - $56/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Compiles and interprets manufacturing process data to identify possible failure modes

• Learns complex cell biology concepts & applies them to root cause investigations

• Works independently and with Process Engineer(s) to understand different failure modes

• Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports

• Facilitates deviation closure through working with quality partners and site quality systems

• Analyzes and summarizes manufacturing data to support root cause investigations

• Analyzes and summarizes characterization data to write root cause investigations

• Utilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify root cause

• Writes technical and thorough investigation reports

Key Requirements and Technology Experience:

• BS in Bio/Chem Science/Engineering or related field

• Immunology education preferred

• 3+ years relevant experience in drug product biopharmaceutical or equivalent industry

• Deviation writing

• cGMP/cGDP

• Ability to prioritize multiple investigations in order to meet deadlines

• Strong scientific and technical acumen including technical writing skills

• Quality management system

• Complex problem-solving skills, including root cause investigation

• Cross-functional collaboration with engineering and quality partners

• Biologics or cell therapy manufacturing

• Trained in Kepner Tregoe Problem Solving

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

J2W:CB3