Responsibilities and experience may include the following: Auditing (internal and external - utilizing risk based strategy. Document systems. Change management utilizing a risk based approach. Operational Excellence utilizing tools such as DMAIC and...
The candidate will be responsible for administering the Change Control and Quality Risk Management processes at the Boulder Manufacturing Site. Responsibilities include: Quality Oversight and facilitation of the site Change Control Review Board and...
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that...
Nitto Denko Technical
QA Manager/Specialist (KLS004)
(Note: position title will be dependent on the level of the candidate’s experience)
Tasks and responsibilities:
• Lead the company’s efforts to become ICH Q7 compliant.
• Review and approve “method validation...
Fibrocell Science, Inc. (Nasdaq: FCSC) is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs. Fibrocell’s most advanced product candidate, azficel-T, uses its proprietary autologous fibroblast...
Alder Biopharmaceuticals, Inc.
This position will have responsibility for supporting product disposition activities and provide Quality oversight of the cGMP biologics manufacturing activities conducted at Alder BioPharmaceutical's Contract Manufacturing...
Ajinomoto Althea, Inc.
Althea is currently seeking a Sr. Quality Investigations Specialist. Reporting to the Vice President of Quality & Regulatory Affairs, this position is responsible for performing a diverse scope of complex activities pertaining to assuring compliance...
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
• Maintain and improve the company’s quality system per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics ...
PLEASE NOTE: Starting in December 2016 this position will have the following shift hours assigned: 3:00 pm - 3:00am (Must be available to work 12 hour shift, 3 days on/4 days off plus one weekend each month) Shift Hours (April 2016 -- November...
About Pfizer A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that...