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GENERAL SUMMARY OF POSITION:

The Quality Control Manager II is responsible for managing the development, implementation and maintenance of quality control microbiology testing and systems for MassBiologics facilities including FDA licensed biologics manufacturing facility. Oversees the daily operations of the QC Microbiology and QC Central Receiving department supporting product testing and monitoring of the manufacturing facility systems and environment. Assures that environmental testing, in-process, bulk, and final container testing is completed on schedule and conforms to cGMP regulations. Reviews and analyze data generated from in-process, bulk, and final container testing. It owns the Contamination Control Strategy of MassBiologics and updated the document as needed. The Manager will act as a Consultant on any item related to industrial Microbiology and Sterility assurance including but not limited to investigations, trending analysis, introduction of best practices, cleaning procedures and agents.

ESSENTIAL FUNCTIONS: 

• Coordinating day-to-day management of the QC Microbiology and QC Central Receiving departments, including high-level planning activities and maintaining communication with other departments.
• Oversee major project milestones and translate these into QC deliverables: ensure appropriate planning and priority setting.
• Assist QC Director in managing operational budget spending by QC Microbiology and QC Central Receiving departments.
• Implement and maintain laboratory information management systems; maintain a system for the storage and administration of stability samples, product retains, assay standards/controls, and samples submitted for QC testing.
• Compile testing data and analyze trends to ensure assays are in a state of control. Analyze data derived from in-process and product testing.
• Develop and implement systems to ensure that QC testing is performed according to SOPs and meets cGMP regulations. Develop relevant SOPs and revises existing SOPs as required. Review SOPs and in-process forms to meet FDA-mandated annual reviews.  Ensure procedures are efficient.
• Maintain substantial technical knowledge related to all testing procedures and relevant manufacturing processes, and readily provide technical support for laboratory staff.
• Ensure assays are state of the art and fit for the purpose of controlling for the quality of both investigational and commercial products and the manufacturing process. Troubleshoot assays as necessary.
• Author assay development and validation procedures and/or equipment when required.
• Investigate, write, and/or manage incident/deviation reports, out-of-specifications reports and other technical reports as needed.
• Hire, manage and train staff. Plan and assign duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establish expectations, define roles, support career development and manage performance, including cross training of staff in microbiology and other QC disciplines.
• Analyze data by statistical and graphical procedures in order to provide pertinent summaries/reports of large volumes of data. Prepare written/oral reports for presentations to management or laboratory staff.
• Perform other additional job related duties as required.

REQUIRED QUALIFICATIONS:

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

Additional responsibilities:

• Participates in the Vendor approval process as required, specifically on key component suppliers, sterilization of components and single use systems (SUS), and services.

• Owns the Contamination control Strategy and its improvement plan to continuously identify, scientifically evaluate, and effectively control potential contamination risks to product quality. Actively reviews and updates the strategy and drives continuous improvement of the manufacturing and control methods.

• Trends and Monitoring systems to ensure detection of environmental contamination.

• Monitors effectiveness of cleaning methods and disinfectants used on Site.

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