What are the responsibilities and job description for the QC Microbiology Manager / Sr Manager position at Abzena?
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Quality Control Manager oversees and manages a team of QC Microbiology Associates. The Quality Control Microbiology team performs Environmental Monitoring (EM) and Utility testing, in-process bioburden and endotoxin testing and release microbiological testing. The Quality Control Manager is a Subject Matter Expert (SME) for compendial and rapid microbiology laboratory methods and is a decision maker for QC Microbiology.
Responsibilities
- Manage the daily routine tasks for the microbiology team by collaborating with quality, manufacturing, facilities and other functions; informing the team of the production needs and scheduling accordingly.
- Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality.
- Generate quarterly and yearly EM / Water trend reports.
- Represent the Microbiology Team and processes during client and regulatory inspections.
- Provide data for monthly site and quarterly global Quality Management Review (QMR)
- Perform and review routine monitoring of EM, pharmaceutical water and gas systems.
- Perform and review bioburden and endotoxin testing.
- Complete analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.
- Responsible for the training of the QC Microbiology Associates and manufacturing on microbiological methods.
- Author and review Quality Control standard operating procedures (SOPs) and assay qualifications. Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities.
- Interact closely with other departments to ensure efficient, compliant and timely execution of lab activities.
- Maintain the functioning of QC Laboratory, including material ordering, inventory control, general housekeeping and other duties.
- Assist and own investigations and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
- Utilize laboratory equipment in accordance with established practices and safety standards.
- Operate to the highest ethical and moral standards.
- Adhere to quality standards set by regulations and Abzena's policies, procedures and mission.
- Communicate effectively with direct manager, colleagues and subordinates.
- Perform performance review of reports and drive their development.
- Participate effectively as a team player in all aspects of Abzena business.
Qualifications
100,000 - $170,000 a year
FLSA : Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Salary : $100,000 - $170,000
