Quality Assurance Manager- Portland, OR

Quality Assurance Manager (Pharmaceutical Experience Requires)

Direct Hire – Portland, OR

Immediate Need for a Quality Assurance Manager to work at a custom manufacturer of fine chemicals to be used in pharmaceutical manufacturing in Portland, OR.  This position is responsible for ensuring compliance of manufacturing processes according to applicable cGMP regulations. The position will be responsible for maintaining, monitoring, and increasing the cGMP compliance of the quality system.

Responsibilities:

• Plan and manage the work of the Quality Assurance department

• Lead certain strategic planning activities and coordination across departments to ensure conformance to each project’s quality requirements

• Manage and oversee the major quality systems, including deviation reporting, change management, CAPA, document control, training, and lot disposition

• Oversee the maintenance of both hard-copy and electronic quality records

• Prepare for, manage, and coordinate customer and regulatory audits, and oversee completion of CAPAs related to audits  

• Manage and perform the additional following responsibilities of the QA department:

o Write, review and/or approve standard operating procedures and other quality documents to ensure compliance with applicable cGMP requirements

o Perform internal audits, cGMP training, quality reviews, and supplier qualification activities

o Review batch production, cleaning, and laboratory data/records 

o Release final products for shipment to customers and/or third parties

 

Requirements:

• 5 years or more of experience working in quality in the pharmaceutical industry

• 1-3 years of management or other relevant leadership experience preferred

• Bachelors Degree or higher (would also consider strong industry experience)

• Must be able to travel on occasion for training, audits, etc.

Why Kelly®?

Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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