Pharmaceutical Quality Control Manager

Columbia Analytical Services, Inc. (CAS) seeks a Quality Control (QC) Manager for its Kelso, WA analytical chemistry laboratory.

 

The Kelso, WA laboratory has historically been an environmental and general testing organization. Approximately three years ago we began building the infrastructure necessary to support a cGMP operation. A relatively large section of our 50,000 ft2 facility was segregated specifically for this purpose. We have positioned ourselves for growth and are seeking a dynamic leader to build the business.

 

Of particular note is we underwent a full systems and data inspection by the FDA in July 2007. That inspection yielded no (483) findings. We have a solid infrastructure built. This position represents an exceptional opportunity for a technical manager with an entrepreneurial bent. The new business is in its infancy, and CAS is committed to building it into a high quality organization similar to our other testing divisions.

 

Primary duties will consist of the oversight of daily operations of the pharmaceutical testing department (manage raw material and component testing, analytical methods transfer and validation, and in-process and finished product release). The testing ranges from various physical parameters to chemical parameters requiring sophisticated instrumentation. Other responsibilities include scheduling work and tracking work flow, supervision of testing staff, and filling staff positions. In addition to the production aspect of the position, the QC Manager is responsible for vendor interaction and some aspects of client management, as well as writing and updating SOPs and product specification manuals. The QC Manager will also work closely with the Business Development Manager to provide technical assistance at trade shows and participate in client visits. The QC Manager will also work directly with the QA Manager to assure strict compliance with cGMP protocol.

 

Requirements:

 B.S./B.A. in scientific-related discipline.  Minimum of five years in the pharmaceutical industry with knowledge of USP procedures and FDA regulations. 

 Proficient with electronic applications, including MS Word, MS Projects, MS Excel, etc.

 Five years experience in a cGMP analytical chemistry laboratory.

 Demonstrated expertise with various analytical chemistry techniques and procedures.

 Strong interpersonal skills; ability to work with colleagues and multiple clients in a professional and organized manner.  Able to effectively lead, train, and develop the pharmaceutical team.

 Ability to identify and define problems; collect, analyze, and interpret data and information; draw appropriate conclusions; propose solutions and/or corrective actions.

 Ability to organize and prioritize work with minimal guidance and to manage projects in a timely and effective manner. Also shall have the ability to reorganize and reschedule work on short notice in order to meet revised deadlines and be sufficiently flexible to understand and handle multiple and varied projects, which may not fall within this job description.

 

Kelso, WA is a small town located at the conflux of the Coweeman and Cowlitz Rivers with the lower Columbia River in Southwest Washington. Kelso offers the advantages of rural living, but is close enough to larger metropolitan areas (Vancouver, WA and Portland, OR) to enable an easy commute if a more populous area is desired. Kelso is in close proximity to the Cascade Mountains, as well as the Pacific Ocean, and offers numerous opportunities for outdoor recreation. The climate is moderate, consisting of four distinct seasons. The cost of living continues to be an advantage for re-locating to the region.

 

The position offers a competitive salary with comprehensive benefits package, including health and life insurance, flexible spending account, 401(k), and ESOP.

 

Submit resume to CAS, 1317 S. 13th Avenue, Kelso, WA 98626.  Equal Opportunity Employer.  www.caslab.com