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Manager, Quality Control

Alexza Pharmaceuticals

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Location:
Mountain View, CA
Posted Date:
6/29/2014
Position Type:
Full time
Job Code:
14-0028
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Chemistry, Manager, Medical Device, Pharmaceutical, PhD, QC, Quality, Quality Control, Validation,

Job Description

Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California, focused on the research, development and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. Our product candidates are based on our proprietary technology, the Staccato® system. The Staccato system vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Our first product, Staccato loxapine, (known commercially as ADASUVE®) has been approved for marketing in the United States by the U.S. Food and Drug Administration and in the European Union by the European Commission. We also have a pipeline of product candidates based on the Staccato system which are in various stages of development for acute and intermittent conditions, for which we believe the Staccato platform is particularly applicable.

We have an exciting opportunity for a QC Manager who will provide leadership, hands on training and coaching and directly perform tasks as needed in the Quality Control (QC) Laboratory Areas.  This position will help to ensure safe, GXP compliant, continuous, and efficient operation of the Quality Control Laboratory areas.  These responsibilities include, but are not limited to the following:
Responsibilities:
•   Assures efficient allocation of resources and oversee day-to-day lab operational workflow
•   Ensures data integrity at all times and communicates, trains and take action as needed regarding data integrity gaps, issues and opportunities
•   Provides data interpretation and other assistance to other analysts as required
•   Assure Test Methods, SOPs, Material Specifications, etc. are up-to-date and manuals are current
•   Assures raw materials, in-process samples, finished product, complaint and stability samples are in a timely manner and all GXP documentation is completed correctly

Maintenance, Troubleshooting and Calibration:
•   Troubleshoot instruments and equipment
•   Ensure proper maintenance and calibration of all equipment and instrumentation
•   Keep equipment operating by certifying instrument performance; enforcing operating instructions; directing preventive maintenance; arranging for repairs; planning equipment replacement
•   Schedule equipment repairs with outside vendors
 
Training and Continuous Improvement:
•   Ensure and document proper training of all analysts
•   Conduct retraining of analysts as necessary
•   Ensure technical skill training of laboratory personnel including instrumentation and equipment inspection, maintenance, cleaning and calibration
•   Identify, assess and lead continuous improvement opportunities

Ensure GXP compliance of lab:
•   Oversee adherence to Test Methods and Laboratory Procedures
•   Oversee proper preparation, storage and use of all standards and solutions
•   Ensure good documentation and data management practices are followed
•   Audit documentation, laboratory practices, issue reports and coordinate correction of GXP deficiencies
•   Oversee adherence to good laboratory practices and GXPs in the QC Lab
•   Participate, conduct and/or write OOS investigations
•   Conduct audit of analytical testing documentation

Other duties:
•   Prepare protocols, reports, procedures, logs, and other documentation as required
•   Validation:  Write and execute validation protocols on instrumentation as required
•   Design and execute lab experiments with input from chemist and quality control manager
•   Keeps accurate records related to testing activities and prepares summary reports of data in a timely manner
•   Approves and releases product, raw materials and other test results
•   Assist in corporate and regulatory audits
•   Conduct special projects to further the objectives of the QC Laboratory as required

Requirements

Skills required:
•   Language:
Ability to read, analyze, and interpret complex documents; Ability to respond effectively to sensitive inquiries or complaints; Clear and concise communication skills, both written and spoken; Ability to write technical reports and articles using original or innovative techniques or style; Ability to make effective and persuasive presentations on complex topics to top management, public groups, and/or boards of directors
•   Mathematical:
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations.
•   Reasoning Ability:
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems; Ability to deal with a variety of abstract and concrete variables; Ability to define problems,
collect data, analyze and establish facts, draw conclusions and assess technical data for compliance with state acceptance criteria, and recommend solutions to complex problems related to quality control issues
•   Leadership:
Provide corporate leadership to execute all validation planning and operations operating under GXP, safety, and quality standards; Ability to interact professionally and effectively with peers, management and leadership both within and outside the department, within the company, and business partners.
•   Supervision:
Receive minimal guidance with respect to general objectives. In the majority of tasks and projects assigned, determine methods, work sequence, scheduling, and how to achieve objectives of assignments; Operate within specific policy guidelines. Manage and direct the selection, training, development, appraisal, and work assignments of laboratory personnel

Education and experience:
•   Bachelor’s degree in chemistry, chemical engineering, pharmaceutics or equivalent degree field is desired. An advanced degree is preferred
•   Preference will be given to candidates who have any the following certifications:  Six Sigma Black Belt (SSBB); Certified Quality Engineer (CQE); Waters HPLC Certification
•   Minimum 8-10 years related experience in a GXP commercial quality control area, with 3-5 years management experience.  R&D experience will be considered, but commercial is a priority
•   Proven experience with testing medical devices and pharmaceuticals or equivalent quality standards is required
•   Analytical method validation experience for pharmaceuticals and device experience a plus.
•   Experience working in a matrix managed team environment and the ability to work effectively with all departments within the company
•   Experience with Aerosol testing, USP, EP, and JP testing methods are a plus
•   Significant experience in troubleshooting, laboratory OOS, OOT investigations, reporting and implementation of effective Corrective and Preventive Actions (CAPA)   

We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth.  

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