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The Quality Control Manager I is responsible for managing quality control testing and systems for an FDA licensed biologics manufacturing facility.  Manages the development and implementation of methods and procedures for testing and evaluating the safety and efficacy of company products. Ensures Quality Control procedures are precise, accurate, and reliable.   Assures that environmental testing, raw materials, in-process, bulk, and final container testing is completed on schedule. Reviews and analyze data generated from in-process, bulk, and final container testing.  Assures finished products conform to government and company standards and satisfy cGMP regulations. 

• Manages the daily operations of the Quality Control group by supervising environmental testing as well as testing of raw materials, in-process, bulk and final container samples. Ensures the accurate and timely completion of testing. Manages non-routine testing required to support investigations.   
• Compiles testing data and analyze trends to ensure assays are in a state of control.  Analyzes data derived from in-process and product testing.
• Develops and validates assays, equipment, and procedures as required.
• Maintains necessary controls and standards. Qualifies new standards, controls, reagents, and materials when necessary.  Ensures adequate inventory of of lab supplies and reagents and proper disposal of hazardous materials.
• Works with senior leadership to develops and implements systems to ensure that QC testing is performed according to SOP’s and meets cGMP regulations.  Writes and revises SOPs as required. Reviews SOPs and in-process forms to meet FDA-mandated annual reviews. 
• Maintains substantial technical knowledge related to all testing procedures and relevant MBL manufacturing processes, and readily provides technical support for laboratory staff. Strives to ensure assays are state of the art and fit for the purpose of controlling for the quality of both MBL products and the manufacturing process.  Troubleshoots assays as necessary.
• Writes incident/deviation reports, out-of-specifications reports and other technical reports as needed.
• Makes recommendations for corrective action necessary to assure conformity with quality specifications. Assures finished products conform to government and company standards and satisfies GMP regulations.
• Hires, manages and trains staff.  Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
• Analyzes data by statistical and graphical procedures in order to provide pertinent summaries/reports of large volumes of data.  May prepare written/oral reports for presentations to management or laboratory staff.
• Performs other additional job related duties as required.

• Requires a Bachelors degree in a scientific discipline or equivalent and a minimum of 5 years of relevant experience including supervisory experience.
• Clear, concise, written and verbal communication and presentation skills 
• Demonstrated problem-solving skills
• Ability to maintain working knowledge and proficiency in applicable cGMP regulations and all current Quality Control procedures within a particular functional area (e.g. microbiological methods for environmental / facility testing, as well as both licensed and IND products)
• Ability to motivate personnel to work effectively and efficiently.
• Demonstrated capability to manage others, assign and schedule work, and conduct performance evaluations
• Experience with documentation and implementation of quality control systems.
• Requires ability to work flexible and, at times, extended hours to meet business needs